Product Code: DXN
FDA class 2
21 CFR 870.1130
System, Measurement, Blood-Pressure, Non-Invasive
Cardiovascular
The Non-Invasive Blood Pressure Measurement System is a cardiovascular device used to measure arterial blood pressure without penetrating the skin, typically using an external cuff and pressure transducer. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance prior to marketing. The product code is DXN and the applicable regulation is 21 CFR 870.1130, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
1187
FEI Numbers
420
Registration Numbers
420
Unique Applicants
516
Years Active
49
Basic Information
- Product Code
- DXN
- Device Class
- FDA class 2
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1187 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250415 | G0 Blood Pressure Monitoring System (G0) | Jul 02, 2025 | Substantially Equivalent | Aktiia SA |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Jun 26, 2025 | Substantially Equivalent | JOYTECH Healthcare Co., Ltd. |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | May 02, 2025 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Apr 30, 2025 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., LTD |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Apr 24, 2025 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Apr 08, 2025 | Substantially Equivalent | Globalcare Medical Technology Co., Ltd |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Mar 14, 2025 | Substantially Equivalent | Korot Co. Ltd. |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Feb 21, 2025 | Substantially Equivalent | Shenzhen Urion Technology Co.,Ltd. |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Feb 19, 2025 | Substantially Equivalent | Shenzhen BSX Technology Electronics Co., Ltd. |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Feb 11, 2025 | Substantially Equivalent | Guangdong Xinyu Electronic and Technology Co., Ltd. |
| K243661 | Electronic Blood Pressure Monitor | Feb 07, 2025 | Substantially Equivalent | Hetaida Technology Co., Ltd. |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Feb 05, 2025 | Substantially Equivalent | Accurate Meditech Inc. |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Feb 03, 2025 | Substantially Equivalent | Guangdong Xinyu Electronic and Technology Co., Ltd. |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Jan 30, 2025 | Substantially Equivalent | Shenzhen Zhongkemingwang Telecommunications Software Corp. |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Jan 23, 2025 | Substantially Equivalent | Murata Vios, Inc. |
| K241066 | BB-613-BPM | Jan 14, 2025 | Substantially Equivalent | BioBeat Technologies Ltd. |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Jan 13, 2025 | Substantially Equivalent | JOYTECH Healthcare Co., Ltd. |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Jan 10, 2025 | Substantially Equivalent | Shenzhen Ruiankang Technology Co., Ltd. |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Nov 26, 2024 | Substantially Equivalent | Shenzhen IMDK Medical Technology Co., Ltd. |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Oct 24, 2024 | Substantially Equivalent | Shenzhen Urion Technology Co.,Ltd. |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Oct 22, 2024 | Substantially Equivalent | AViTA Corporation |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Oct 16, 2024 | Substantially Equivalent | Shenzhen HBcare Technology Co.,Ltd |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Oct 04, 2024 | Substantially Equivalent | Shenzhen Finicare Co., Ltd. |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | Aug 21, 2024 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K241129 | Upper Arm Electronic Blood Pressure Monitor | Jul 03, 2024 | Substantially Equivalent | ShenZhen GoodlyMed Technology Co., Ltd. |
| K240729 | Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) | Jun 14, 2024 | Substantially Equivalent | Shenzhen Pango Medical Electronics Co., Ltd. |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | Jun 07, 2024 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | May 31, 2024 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | Apr 29, 2024 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | Apr 22, 2024 | Substantially Equivalent | Andon Health Co Ltd |
| K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Mar 26, 2024 | Substantially Equivalent | Shenzhen Hingmed Medical Instrument Co., Ltd. |
| K233146 | Blood Pressure Monitor | Mar 19, 2024 | Substantially Equivalent | Shenzhen Jamr Technology Co., Ltd. |
| K233799 | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Mar 15, 2024 | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. |
| K231303 | Arm-type Fully Automatic Digital Blood Pressure Monitor | Jan 26, 2024 | Substantially Equivalent | Joytech Healthcare Co., Ltd |
| K230996 | Pursuant Health Kiosk (G1.D5) | Jan 04, 2024 | Substantially Equivalent | Pursuant Health |
| K233130 | Blood Pressure Monitor | Dec 20, 2023 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K231478 | Digital Blood Pressure Monitor (Model: YB-800) | Dec 15, 2023 | Substantially Equivalent | Wenzhou Yosun Medical Technology Co.,Ltd |
| K232815 | Wrist Blood Pressure Monitor | Dec 11, 2023 | Substantially Equivalent | Zhuhai Yueja Medical Device Technology Co.,Ltd. |
| K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Dec 08, 2023 | Substantially Equivalent | Nanowear Inc. |
| K232814 | Electronic Blood Pressure Monitor | Dec 05, 2023 | Substantially Equivalent | Zhuhai Yueja Medical Device Technology Co.,Ltd. |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Dec 05, 2023 | Substantially Equivalent | HeTaiDa Technology Co., Ltd. |
| K232713 | Blood Pressure Monitor | Nov 28, 2023 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K231250 | Digital Blood Pressure Monitor | Nov 28, 2023 | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. |
| K232621 | Blood pressure monitor | Nov 22, 2023 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | Nov 22, 2023 | Substantially Equivalent | Guangdong Genial Technology Co., Ltd. |
| K231310 | Electronic Blood Pressure Monitor | Oct 27, 2023 | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. |
| K230919 | Acumen IQ finger cuff | Oct 24, 2023 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K231050 | Arm Blood Pressure Monitor | Oct 11, 2023 | Substantially Equivalent | Alicn Medical Shenzhen, Inc |
| K223873 | Boppli Infant Blood Pressure Monitor | Sep 29, 2023 | Substantially Equivalent | PyrAmes Inc. |
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Sep 18, 2023 | Substantially Equivalent | Shenzhen Finicare Co., Ltd. |
| K231542 | Digital Blood Pressure Monitor WBP Series | Sep 07, 2023 | Substantially Equivalent | Weony (Shenzhen) Technology Co., Ltd. |
| K230649 | Arm Blood Pressure Monitor | Sep 07, 2023 | Substantially Equivalent | Alicn Medical Shenzhen, Inc |
| K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Aug 25, 2023 | Substantially Equivalent | Joytech Healthcare Co.,Ltd |
| K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Aug 25, 2023 | Substantially Equivalent | Shenzhen Jamr Technology Co., Ltd. |
| K230642 | Electronic Blood Pressure Monitor | Aug 11, 2023 | Substantially Equivalent | Dongguan kangweile Electronic Technology Co., Ltd. |
| K231174 | BPBIO750 | Aug 02, 2023 | Substantially Equivalent | InBody Co, Ltd. |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Jul 26, 2023 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. |
| K223374 | Blood Pressure Monitor | Jun 30, 2023 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K230176 | Upper Arm Blood Pressure Monitor | Jun 29, 2023 | Substantially Equivalent | Shenzhen Yolanda Technology Co., Ltd. |
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Jun 28, 2023 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K222658 | Accurate 24 Non-invasive blood pressure monitor | Jun 21, 2023 | Substantially Equivalent | Accurate Meditech Inc. |
| K223291 | Electronic Blood Pressure Monitor | Jun 14, 2023 | Substantially Equivalent | Shenzhen Pango Medical Electronics Co., Ltd. |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | May 19, 2023 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | May 05, 2023 | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. |
| K221742 | CONNEQT PULSE | Apr 21, 2023 | Substantially Equivalent | Atcor Medical |
| K223332 | Task Force CORE | Apr 12, 2023 | Substantially Equivalent | CNSystems Medizintechnik GmbH |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Apr 10, 2023 | Substantially Equivalent | Famidoc Technology Company Limited |
| K222394 | Electronic Sphygmomanometers | Mar 03, 2023 | Substantially Equivalent | Qingdao Yasee Medical Device Co., Ltd. |
| K222869 | Arm Blood Pressure Monitor | Feb 15, 2023 | Substantially Equivalent | Andon Health Co., Ltd. |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | Feb 03, 2023 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | Dec 01, 2022 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. |
| K222160 | GUS610 Blood pressure monitor | Nov 22, 2022 | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. |
| K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Nov 07, 2022 | Substantially Equivalent | Edwards Life Sciences LLC |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Oct 17, 2022 | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply CO.,LTD. |
| K221913 | Arm Blood Pressure Monitor | Oct 12, 2022 | Substantially Equivalent | Alicn Medical Shenzhen,Inc |
| K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Oct 07, 2022 | Substantially Equivalent | InBody Co, Ltd. |
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | Oct 06, 2022 | Substantially Equivalent | A&D Company, Ltd |
| K220220 | Electronic Sphygmomanometer (Model: LT-P30) | Oct 03, 2022 | Substantially Equivalent | Zhuhai Linte Medical Instrument Co., Ltd. |
| K213023 | Blood Pressure Monitor(Model:Y30001) | Sep 30, 2022 | Substantially Equivalent | Zhangzhou Easepal Medical Science And Technology Co.,LTD |
| K221040 | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) | Aug 31, 2022 | Substantially Equivalent | Jiangxi AICARE Medical Technology Co., Ltd |
| K221486 | INDEX BPM | Aug 30, 2022 | Substantially Equivalent | Ya Horng Electronic Co., Ltd. |
| K220676 | Blood Pressure Monitor | Aug 29, 2022 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K221212 | Upper Arm Blood Pressure Monitor | Aug 26, 2022 | Substantially Equivalent | Shenzhen Yolanda Technology Co., Ltd |
| K220886 | Upper Arm Type Blood Pressure Monitor | Jul 27, 2022 | Substantially Equivalent | Shenzhen Jamr Technology Co.,Ltd |
| K220651 | Wrist Type Blood Pressure Monitor | Jun 30, 2022 | Substantially Equivalent | Shenzhen Jamr Medical Technology Co., Ltd |
| K220106 | QardioArm 2 | Jun 15, 2022 | Substantially Equivalent | Qardio Inc |
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | May 31, 2022 | Substantially Equivalent | Shenzhen Finicare Co., Ltd. |
| K201302 | LiveOne | May 04, 2022 | Substantially Equivalent | LiveMetric (Medical) S.A. |
| K213699 | CareTaker Monitor App | Mar 30, 2022 | Substantially Equivalent | Caretaker Medical, LLC |
| K213189 | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Mar 01, 2022 | Substantially Equivalent | Joytech Healthcare Co., Ltd |
| K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Feb 18, 2022 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. |
| K212312 | RA-T59 Wrist blood pressure monitor | Jan 27, 2022 | Substantially Equivalent | LotusNine Medical Limited |
| K211532 | Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 | Jan 19, 2022 | Substantially Equivalent | Yibin Junxin Electronics Technology Co., Ltd. |
| K212877 | Arm Blood Pressure Monitor | Jan 12, 2022 | Substantially Equivalent | Alicn Medical Shenzhen,Inc |
| K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Jan 05, 2022 | Substantially Equivalent | JOYTECH HEALTHCARE CO.,LTD |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Nov 04, 2021 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K212171 | Electronic Blood Pressure Monitor | Nov 01, 2021 | Substantially Equivalent | Dongguan Kangweile Electronic Technology Co., Ltd. |
| K210563 | Arm Blood Pressure Monitor | Oct 15, 2021 | Substantially Equivalent | Alicn Medical Shenzhen,Inc |
| K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Oct 01, 2021 | Substantially Equivalent | Edan Instruments, Inc. |
| K210152 | Automatic Digital Blood Pressure Monitor | Sep 23, 2021 | Substantially Equivalent | AVICHE Shandong Medical Technology Co, Ltd. |
| K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Sep 08, 2021 | Substantially Equivalent | Health & Life Co., Ltd |
| K211041 | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | Aug 30, 2021 | Substantially Equivalent | Shenzhen Yuezhongxing Technology Co., Ltd. |
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | Aug 13, 2021 | Substantially Equivalent | Caretaker Medical |
| K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 | Aug 13, 2021 | Substantially Equivalent | Weony (Shenzhen) Technology Co., Ltd. |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | Jul 30, 2021 | Substantially Equivalent | Andon Health Co., Ltd. |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Jul 29, 2021 | Substantially Equivalent | Andon Health Co., Ltd. |
| K201914 | HRVWatch-Mini Wrist Monitor | Jun 07, 2021 | Substantially Equivalent | Taiwan Scientific Corporation |
| K210435 | Automatic Arm Electronic Blood Pressure Monitor | May 12, 2021 | Substantially Equivalent | Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor | Apr 28, 2021 | Substantially Equivalent | Contec Medical Systems Co., Ltd. |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Apr 08, 2021 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Apr 01, 2021 | Substantially Equivalent | Omron Healthcare, Inc. |
| K202891 | Blood Pressure Monitor | Mar 09, 2021 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K201332 | Meditech ABPM-06 (BP6) | Feb 10, 2021 | Substantially Equivalent | Meditech Ltd. |
| K193387 | Arm Electronic Sphygmomanometer | Jan 27, 2021 | Substantially Equivalent | ShenZhen Changkun Technology CO.,LTD. |
| K193386 | Wrist Electronic Sphygmomanometer | Jan 27, 2021 | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. |
| K202934 | Blood Pressure Monitor | Jan 26, 2021 | Substantially Equivalent | Bioland Technology Ltd. |
| K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Jan 22, 2021 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K200560 | InBody | Jan 06, 2021 | Substantially Equivalent | InBody Co. Ltd. |
| K202372 | Upper Arm Electronic Blood Pressure Monitor | Dec 30, 2020 | Substantially Equivalent | Conmo Electronic Company Limited |
| K200346 | Wrist Type Blood Pressure Monitor | Dec 17, 2020 | Substantially Equivalent | Avita Corporation |
| K202599 | Transtek Wrist Blood Pressure Monitor | Dec 06, 2020 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. |
| K200716 | Electronic Blood Pressure Monitor | Dec 04, 2020 | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. |
| K200442 | InBody | Dec 04, 2020 | Substantially Equivalent | InBody Co. Ltd. |
| K200434 | V20, V20a, AVSM3 SNF | Oct 09, 2020 | Substantially Equivalent | Mediana Co., Ltd. |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Sep 21, 2020 | Substantially Equivalent | Bioland Technology Ltd. |
| K200939 | Electronic Blood Pressure Monitor | Aug 20, 2020 | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd |
| K200649 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Aug 03, 2020 | Substantially Equivalent | Joytech Healthcare Co., Ltd |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Jul 23, 2020 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K193456 | Arm Blood Pressure Monitor | Jul 16, 2020 | Substantially Equivalent | Ningbo Ranor Medical Science & Technology Co., Ltd. |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | Jul 12, 2020 | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | Jul 12, 2020 | Substantially Equivalent | Dongguan E-Test Technology Co., LTD |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | Jul 10, 2020 | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd |
| K200437 | Blood Pressure Monitor | Jun 25, 2020 | Substantially Equivalent | Shenzhen Jamr Technology Co., Ltd. |
| K193348 | Blood Pressure Monitor | Jun 25, 2020 | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Jun 18, 2020 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Jun 12, 2020 | Substantially Equivalent | Health & Life Co., Ltd |
| K190982 | Automatic Digital Blood Pressure Monitor | May 29, 2020 | Substantially Equivalent | Xiamen Ants Bro Technology Co., Ltd. |
| K200287 | BP-BT Kiosk | May 15, 2020 | Substantially Equivalent | LD Technology LLC |
| K191745 | Medtronic Commander Flex | May 15, 2020 | Substantially Equivalent | Medtronic Care Management Services |
| K192609 | Globalcare Blood Pressure Monitor | Apr 21, 2020 | Substantially Equivalent | Globalcare Medical Technology Co., Ltd |
| K191894 | Upper Arm Blood Pressure Monitor | Feb 21, 2020 | Substantially Equivalent | ShenZhen ZhengKang Technology Co., Ltd. |
| K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | Jan 23, 2020 | Substantially Equivalent | Seca GmbH & Co. Kg |
| K192023 | Arm Blood Pressure Monitor | Dec 23, 2019 | Substantially Equivalent | Truly Instrument Limited |
| K191673 | Upper Arm Blood Pressure Monitor | Nov 27, 2019 | Substantially Equivalent | Famidoc Technology Company Limited |
| K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Sep 16, 2019 | Substantially Equivalent | Health & Life Co. ltd. |
| K183521 | CNAP Monitor | Sep 11, 2019 | Substantially Equivalent | CNSystems Medizintechnik GmbH |
| K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Aug 30, 2019 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K191180 | Electronic Blood Pressure Monitor | Aug 23, 2019 | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. |
| K190207 | Blood Pressure Monitor | Aug 19, 2019 | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. |
| K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | Aug 07, 2019 | Substantially Equivalent | Vita-Course Technologies Co., Ltd. |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | Aug 02, 2019 | Substantially Equivalent | Shenzhen Med-link Electronics Tech Co, Ltd. |
| K190886 | Non-invasive blood pressure measurement systems | Jul 29, 2019 | Substantially Equivalent | Joytech Healthcare Co., Ltd |
| K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Jul 22, 2019 | Substantially Equivalent | Grandway Technology (Shenzhen) Limited |
| K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Jul 10, 2019 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Jul 03, 2019 | Substantially Equivalent | Shenzhen BSX Technology Electronics Co., Ltd. |
| K190927 | Oscillometric Blood Pressure Monitor | Jun 24, 2019 | Substantially Equivalent | Rudolf Riester GmbH |
| K190130 | The ClearSight finger cuffs | Jun 21, 2019 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Jun 13, 2019 | Substantially Equivalent | Health & Life Co., Ltd. |
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | Jun 04, 2019 | Substantially Equivalent | Andon Health Co., Ltd. |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | May 20, 2019 | Substantially Equivalent | Health & Life Co., Ltd. |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | May 16, 2019 | Substantially Equivalent | Andon Health Co., Ltd. |
| K173895 | Tel-O-Graph | May 16, 2019 | Substantially Equivalent | I.E.M. Industrielle Entwicklung and Medizintechnik |
| K181894 | TOF-Cuff monitor | May 09, 2019 | Substantially Equivalent | RGB Medical Devices SA |
| K173065 | A&D Medical Blood Pressure Monitors | Apr 24, 2019 | Substantially Equivalent | A&D Company, Ltd |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Apr 17, 2019 | Substantially Equivalent | Omron Healthcare, Inc. |
| K181832 | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device | Apr 09, 2019 | Substantially Equivalent | Guangdong Transtek Medical Electronics Co. Ltd |
| K181931 | GMC Upper Arm Automatic Blood Pressure Monitor | Apr 04, 2019 | Substantially Equivalent | GMC Inc. |
| K183491 | Arm Blood Pressure Monitor | Mar 24, 2019 | Substantially Equivalent | Xuzhou Yongkang Electronic Science Technology Co., Ltd |
| K173191 | A&D Medical Blood Pressure Monitors | Mar 21, 2019 | Substantially Equivalent | A&D Company, Ltd. |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Mar 14, 2019 | Substantially Equivalent | Omron Healthcare, Inc. |
| K183469 | Microlife Digital Blood Pressure Monitor | Mar 12, 2019 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K182495 | Electronic Blood Pressure Monitor | Mar 03, 2019 | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. |
| K181930 | GMC Wrist Automatic Blood Pressure Monitor | Feb 14, 2019 | Substantially Equivalent | GMC Inc. |
| K182934 | FORA P100 Blood Pressure Monitoring System | Feb 12, 2019 | Substantially Equivalent | TaiDoc Technology Corporation |
| K180435 | Arm Blood Pressure Monitor | Jan 03, 2019 | Substantially Equivalent | Alicn Medical (Shenzhen), Inc |
| K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System | Nov 30, 2018 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Nov 09, 2018 | Substantially Equivalent | Omron Healthcare, Inc. |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Nov 08, 2018 | Substantially Equivalent | Omron Healthcare, Inc. |
| K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Nov 06, 2018 | Substantially Equivalent | Finapres Medical Systems B.V. |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Nov 02, 2018 | Substantially Equivalent | Omron Healthcare, Inc. |
| K180240 | Full Automatic(NIBP) Blood Pressure Monitor | Oct 17, 2018 | Substantially Equivalent | Health & Life Co. Ltd. |
| K182018 | Bluetooth blood pressure monitor | Oct 06, 2018 | Substantially Equivalent | Shenzhen Kingyield Technology Co., Ltd. |
| K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | Aug 29, 2018 | Substantially Equivalent | Shenzhen Combei Technology CO., LTD |
| K173024 | Non-invasive blood pressure measurement systems | Aug 22, 2018 | Substantially Equivalent | Joytech Healthcare Co.,Ltd |
| K180155 | Arm Type Blood Pressure Monitor | Aug 03, 2018 | Substantially Equivalent | Avita Corporation |
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Jun 21, 2018 | Substantially Equivalent | HealthSTATS International Pte Ltd |
| K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 | Jun 18, 2018 | Substantially Equivalent | Ageless Health Industrial Co., Ltd |
| K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Apr 18, 2018 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | Apr 10, 2018 | Substantially Equivalent | Grandway Technology (Shenzhen) Limited |
| K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D | Mar 27, 2018 | Substantially Equivalent | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd |
| K171937 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Mar 16, 2018 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K162616 | Wrist Type Blood Pressure Monitor | Mar 09, 2018 | Substantially Equivalent | Xuzhou Yongkang Electronic Science Technology Co., Ltd |
| K172972 | Wrist Type Automatic Blood Pressure Monitor | Mar 02, 2018 | Substantially Equivalent | Shenzhen Jiacom Technology Co., Ltd |
| K171668 | Bluetooth blood pressure monitor | Feb 26, 2018 | Substantially Equivalent | Visiomed Group SA |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | Feb 21, 2018 | Substantially Equivalent | Honsun(Nantong)Co.,Ltd |
| K172896 | Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 | Jan 26, 2018 | Substantially Equivalent | Shenzhen Jiacom Technology Co ., Ltd |
| K171833 | Digital Blood Pressure Monitor-Wrist Style | Jan 10, 2018 | Substantially Equivalent | Shenzhen Combei Technology CO., LTD |
| K170497 | V10 | Dec 15, 2017 | Substantially Equivalent | Mediana Co., Ltd. |
| K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | Nov 22, 2017 | Substantially Equivalent | Joytech Healthcare Co., Ltd. |
| K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | Nov 21, 2017 | Substantially Equivalent | Truly Instrument Ltd. |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537 | Oct 27, 2017 | Substantially Equivalent | Honsun(Nantong) Co., Ltd. |
| K170454 | Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U | Oct 25, 2017 | Substantially Equivalent | Honsun(Nantong) Co., Ltd. |
| K172498 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y | Oct 13, 2017 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K170151 | Electronic Blood Pressure Monitor | Oct 13, 2017 | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. |
| K172739 | higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) | Oct 10, 2017 | Substantially Equivalent | higi SH LLC |
| K170467 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Aug 30, 2017 | Substantially Equivalent | Microlife Intellectual Property GmbH |
| K171062 | BP5S Wireless Blood Pressure Monitor | Aug 01, 2017 | Substantially Equivalent | Andon Health Co., Ltd. |
| K161845 | Electronic Blood Pressure Monitor | Jul 31, 2017 | Substantially Equivalent | Shenzhen Pango Electronic Co.,Ltd. |
| K171282 | Fully Automatic Blood Pressure Monitor | Jul 27, 2017 | Substantially Equivalent | Andon Health Co., Ltd |
| K163648 | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series | Jul 07, 2017 | Substantially Equivalent | Grandway Technology (Shenzhen) Limited |
| K170966 | TONOPORT VI | Jun 14, 2017 | Substantially Equivalent | PAR Medizintechnik GmbH & Co. KG |
| K163679 | Digital Automatic Blood Pressure Monitor MD3600 | Jun 07, 2017 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K162463 | Matrix Data Management System | May 24, 2017 | Substantially Equivalent | GLOBAL INSTRUMENTATION, LLC |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | May 17, 2017 | Substantially Equivalent | A&D Company, Ltd. |
| K163276 | Fully Automatic Electronic Blood Pressure Monitor | May 11, 2017 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K163606 | Digital Blood Pressure Monitor-Automatic Upper Arm Style | May 09, 2017 | Substantially Equivalent | Shenzhen Combei Technology CO., LTD |
| K163683 | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | May 03, 2017 | Substantially Equivalent | A&D COMPANY, LTD |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | Apr 21, 2017 | Substantially Equivalent | Caretaker Medical, LLC |
| K163235 | HEM-9210T | Apr 20, 2017 | Substantially Equivalent | Omron Healthcare, Inc. |
| K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Apr 18, 2017 | Substantially Equivalent | FINAPRES MEDICAL SYSTEMS BV |
| K161712 | Arm automatic blood pressure monitor | Apr 05, 2017 | Substantially Equivalent | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
| K161530 | Bluetooth blood pressure monitor | Mar 31, 2017 | Substantially Equivalent | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
| K153600 | Consult Station TS | Mar 17, 2017 | Substantially Equivalent | H4D SAS |
| K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | Feb 21, 2017 | Substantially Equivalent | Omron Healthcare, Inc. |
| K162668 | Fully Automatic Electronic Blood Pressure Monitor | Feb 14, 2017 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K162089 | Blood Pressure Monitor | Feb 10, 2017 | Substantially Equivalent | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
| K162915 | Fully Automatic Electronic Blood Pressure Monitor | Feb 08, 2017 | Substantially Equivalent | Andon Health Co., Ltd. |
| K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Feb 08, 2017 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K162144 | iHealth Wireless Blood Pressure Monitor | Feb 01, 2017 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Jan 19, 2017 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Nov 22, 2016 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K161708 | Arm automatic blood pressure monitor | Nov 22, 2016 | Substantially Equivalent | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD |
| K162230 | Fully Automatic Electronic Blood Pressure Monitor | Nov 18, 2016 | Substantially Equivalent | ADON HEALTH CO., LTD. |
| K160349 | Electronic Sphygmomanometer | Nov 03, 2016 | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. |
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Oct 24, 2016 | Substantially Equivalent | TRULY INSTRUMENT LIMITED |
| K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device | Oct 14, 2016 | Substantially Equivalent | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
| K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Sep 21, 2016 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K152659 | V10 | Aug 25, 2016 | Substantially Equivalent | MEDIANA CO., LTD |
| K160565 | Fully Automatic Electronic Blood Pressure Monitor | Aug 10, 2016 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K160563 | Fully Automatic Electronic Blood Pressure Monitor | Aug 04, 2016 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K153557 | ABPM 7100, Hypertension Management Software | Jul 19, 2016 | Substantially Equivalent | I.E.M. GMBH |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Jul 06, 2016 | Substantially Equivalent | HEALTH & LIFE CO.,LTD. |
| K160439 | SunTech CT40 Spot-check Vital Signs Device | Jul 06, 2016 | Substantially Equivalent | SUNTECH MEDICAL |
| K153033 | Digital Blood Pressure Monitor | Jun 24, 2016 | Substantially Equivalent | SUZHOU SUNSPIRI CO., LTD. |
| K161156 | Full Automatic (NIBP) Blood Pressure Monitor | Jun 14, 2016 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform | Jun 01, 2016 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC |
| K153552 | AGE Automatic Upper Arm Blood Pressure Monitor | Jun 01, 2016 | Substantially Equivalent | Ageless Health Industrial Co., Ltd |
| K152415 | Digital Blood Pressure Monitor | May 06, 2016 | Substantially Equivalent | SUZHOU SUNSPIRIT CO., LTD. |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Apr 22, 2016 | Substantially Equivalent | SHENZHEN URION TECHNOLOGY CO.,LTD |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | Apr 13, 2016 | Substantially Equivalent | A&D COMPANY, LTD |
| K152107 | HealthChek Network Health Station | Apr 12, 2016 | Substantially Equivalent | HEALTHCHEK NETWORK, LLC |
| K160336 | Full Automatic (NIBP) Blood Pressure Monitor | Mar 29, 2016 | Substantially Equivalent | Health & Life Co., Ltd. |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | Mar 18, 2016 | Substantially Equivalent | CARETAKER MEDICAL, LLC |
| K160145 | Full Automatic (NIBP) Blood Pressure Monitor | Mar 13, 2016 | Substantially Equivalent | Health & Life Co., Ltd. |
| K152831 | Spot Skan | Feb 23, 2016 | Substantially Equivalent | SKANRAY TECHNOLOGIES PRIVATE LIMITED |
| K151520 | Oscar 2 | Feb 19, 2016 | Substantially Equivalent | SunTech Medical, Inc. |
| K151258 | Arm automatic blood pressure monitor | Feb 18, 2016 | Substantially Equivalent | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
| K153077 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Feb 12, 2016 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K160014 | iHealth Track Blood Pressure Monitor | Feb 02, 2016 | Substantially Equivalent | Andon Health Co., Ltd |
| K153214 | Full Automatic (NIBP) Blood Pressure Monitor | Jan 07, 2016 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K153450 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Dec 16, 2015 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K150908 | XM-01 Electronic Automatic Blood Pressure Monitor | Dec 16, 2015 | Substantially Equivalent | Sky Innovation Technology ( Shanghai) Limited |
| K151127 | higi Station | Dec 08, 2015 | Substantially Equivalent | higi SH LLC |
| K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | Nov 09, 2015 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K152770 | ProBP 2400 Digital Blood Pressure Device | Oct 21, 2015 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K151415 | Oregon Scientific | Oct 21, 2015 | Substantially Equivalent | IDT TECHNOLOGY LIMITED |
| K152687 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Oct 16, 2015 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K152483 | Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series | Sep 29, 2015 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K152003 | iHealth BP3L Wireless Blood Pressure Monitor | Sep 24, 2015 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K152379 | iHealth View BP7S Wireless Blood Pressure Wrist Monitor | Sep 23, 2015 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K151460 | Fully Automatic Electronic Blood Pressure Monitor | Sep 08, 2015 | Substantially Equivalent | ANDON HEALTH CO., LTD. |
| K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Sep 02, 2015 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
| K150311 | Full Automatic (NIBP)Blood Pressure Monitor | Aug 18, 2015 | Substantially Equivalent | Health & Life Co., Ltd. |
| K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Aug 07, 2015 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K151583 | Digital Automatic Wrist Blood Pressure Monitor MD3900 | Aug 07, 2015 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K143735 | Digital Automatic Blood Pressure Monitor MD2300 | Jul 23, 2015 | Substantially Equivalent | Grandway Technology (Shenzhen) Limited |
| K151330 | Microlife Wrist Watch Blood Pressure Monitor | Jul 14, 2015 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND |
| K140762 | AUTOMATIC BLOOD PRESSURE MONITOR | Jul 02, 2015 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K151281 | AGE Automatic Wrist Blood Pressure Monitor | Jun 30, 2015 | Substantially Equivalent | DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
| K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] | Jun 11, 2015 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K143734 | Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 | May 02, 2015 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K141984 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Apr 29, 2015 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K143341 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Apr 21, 2015 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Apr 17, 2015 | Substantially Equivalent | FUDAKANG INDUSTRIAL CO., LTD |
| K140360 | HEALTH KIOSK | Apr 10, 2015 | Substantially Equivalent | ENGAGEMENTHEALTH, LLC |
| K143733 | Digital Automatic Wrist Blood Pressure Monitor MD2400 | Apr 03, 2015 | Substantially Equivalent | Grandway Technology (Shenzhen) Limited |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | Apr 03, 2015 | Substantially Equivalent | SHENZHEN URION TECHNOLOGY CO., LTD. |
| K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) | Apr 02, 2015 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K143108 | HealthGuard-15 | Mar 27, 2015 | Substantially Equivalent | FUTREX, INC. |
| K141460 | FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR | Mar 20, 2015 | Substantially Equivalent | FINAPRES MEDICAL SYSTEMS BV |
| K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Dec 19, 2014 | Substantially Equivalent | Health & Life Co.,Ltd. |
| K142917 | BP652N (HEM-6300-Z) | Dec 01, 2014 | Substantially Equivalent | OMRON Healthcare, Inc |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Nov 25, 2014 | Substantially Equivalent | MORTARA INSTRUMENT, INC. |
| K141755 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Nov 19, 2014 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K142088 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES | Oct 31, 2014 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K141416 | BLOOD PRESSURE MONITOR | Oct 09, 2014 | Substantially Equivalent | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
| K141201 | A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR | Oct 08, 2014 | Substantially Equivalent | A & D CO., LTD. |
| K141160 | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | Oct 07, 2014 | Substantially Equivalent | A & D CO., LTD. |
| K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | Sep 26, 2014 | Substantially Equivalent | SPACELABS HEALTHCARE LTD. |
| K140928 | ABPM7100 | Sep 15, 2014 | Substantially Equivalent | I.E.M. GMBH |
| K141924 | HD BLOOD PRESSURE MONITOR | Sep 08, 2014 | Substantially Equivalent | BIOCARE ASIA CORPORATION LTD. |
| K141083 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR | Aug 22, 2014 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K134029 | BELTER BLOOD PRESSURE METER | Jul 25, 2014 | Substantially Equivalent | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
| K140572 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Jul 02, 2014 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
| K140121 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Jul 02, 2014 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K141179 | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR | Jun 27, 2014 | Substantially Equivalent | A & D CO., LTD. |
| K140583 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES | Jun 18, 2014 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K140067 | QARDIOARM | Jun 18, 2014 | Substantially Equivalent | QARDIO, INC. |
| K140312 | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM | Jun 13, 2014 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K140412 | ANS1 SOFTWARE | May 22, 2014 | Substantially Equivalent | LD TECHNOLOGY LLC |
| K133588 | FORA CARE BLOOD PRESSURE MONITORING SYSTEM | Apr 25, 2014 | Substantially Equivalent | FORA CARE INC. |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | Mar 24, 2014 | Substantially Equivalent | WITHINGS |
| K131916 | BPROSOFT CASP PC SOFTWARE | Mar 11, 2014 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K133619 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES | Mar 05, 2014 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K133618 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES | Mar 05, 2014 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K133383 | HEM-7320 | Mar 04, 2014 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K131788 | HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE | Mar 04, 2014 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K131245 | OREGON SCINTIFIC | Jan 17, 2014 | Substantially Equivalent | IDT TECHNOLOGY LIMITED |
| K133379 | HEM-7311 | Jan 16, 2014 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K130325 | ARM AUTOMATIC BLOOD PRESSURE MONITOR | Dec 24, 2013 | Substantially Equivalent | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
| K132240 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES | Dec 16, 2013 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K131026 | BOSCH BLOOD PRESSURE METER (BP5000 BT) | Nov 14, 2013 | Substantially Equivalent | ROBERT BOSCH HEALTHCARE SYSTEMS, INC. |
| K132627 | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Oct 23, 2013 | Substantially Equivalent | HONSUN (NANTONG) CO., LTD. |
| K131749 | HEM-6221 | Oct 07, 2013 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K130232 | ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM | Sep 17, 2013 | Substantially Equivalent | JINXINBAO ELECTRONIC CO.,LTD |
| K123130 | ANSWATCH WRIST MONITOR MODEL TS-0411 | Sep 17, 2013 | Substantially Equivalent | TAIWAN SCIENTIFIC CORPORATION |
| K130925 | AUTOMATIC BLOOD PRESSURE MONITOR | Sep 12, 2013 | Substantially Equivalent | HONSUN (NANTONG) CO., LTD. |
| K131064 | BIOSPACE | Sep 04, 2013 | Substantially Equivalent | BIOSPACE CORPORATION LIMITED |
| K131558 | PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 | Aug 30, 2013 | Substantially Equivalent | SHENZHEN PANGO ELECTRONIC CO., LTD |
| K123882 | AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR | Aug 14, 2013 | Substantially Equivalent | AGELESS HEALTH INDUSTRIAL |
| K131742 | HEM-6131 | Jul 24, 2013 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K131203 | IHEALTH CLOUD | Jul 19, 2013 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K131463 | WRIST AUTOMATIC BLOOD PRESSURE MONITOR | Jul 08, 2013 | Substantially Equivalent | HONSUN (NANTONG) CO., LTD |
| K131395 | TRANSTEK BLOOD PRESSURE MONITOR | Jun 19, 2013 | Substantially Equivalent | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
| K130564 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Jun 19, 2013 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K130563 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Jun 18, 2013 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K131569 | PG-800A SERIES | Jun 14, 2013 | Substantially Equivalent | SHENZHEN PANGO ELECTRONIC CO., LTD |
| K131346 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Jun 06, 2013 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K131121 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | May 29, 2013 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K123800 | WRIST AUTOMATIC BLOOD PRESSURE MONITOR | May 15, 2013 | Substantially Equivalent | LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
| K122013 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) | May 13, 2013 | Substantially Equivalent | MICROLIFE CORP. |
| K123600 | DIGITAL BLOOD PRESSURE MONITOR | May 03, 2013 | Substantially Equivalent | LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
| K123539 | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK | Apr 22, 2013 | Substantially Equivalent | STAYHEALTHY, INC. |
| K122381 | NEXFIN MODEL 2 | Apr 22, 2013 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K122076 | PERSONAL HEALTH CENTER (PHC) | Apr 15, 2013 | Substantially Equivalent | ADFLOW HEALTH NETWORKS INC |
| K123498 | BP652N (HEM-6300-Z) | Mar 21, 2013 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K122098 | APPS-HEALTH01 | Mar 21, 2013 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K123073 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 | Mar 11, 2013 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K123780 | TRANSTEK BLOOD PRESSURE MONITOR | Mar 01, 2013 | Substantially Equivalent | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
| K120675 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES | Feb 14, 2013 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K120673 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES | Feb 14, 2013 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K122810 | COMPACT DIGITAL BLOOD PRESSURE MONITOR | Feb 08, 2013 | Substantially Equivalent | THERMOR LTD. |
| K123839 | WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 | Jan 11, 2013 | Substantially Equivalent | NINGBO DIAIER ELECTRONIC CO., LTD. |
| K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Dec 21, 2012 | Substantially Equivalent | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
| K121266 | CARDIOSCOPE | Dec 11, 2012 | Substantially Equivalent | PULSECOR LIMITED |
| K123446 | TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM | Dec 07, 2012 | Substantially Equivalent | United States GTM Medical Devices, Inc. |
| K123020 | BLIP MODEL BP-700WF | Nov 28, 2012 | Substantially Equivalent | CAREMATIX INC. |
| K122443 | UFIT TEN-10 | Nov 20, 2012 | Substantially Equivalent | BIOSIGN TECHNOLOGIES, INC. |
| K122129 | SPHYGMOCOR XCEL | Nov 16, 2012 | Substantially Equivalent | ATCOR MEDICAL |
| K122401 | TANGO M2 BLOOD PRESSURE MONITOR | Nov 02, 2012 | Substantially Equivalent | SUNTECH MEDICAL, INC. |
| K120545 | HX-461 | Oct 23, 2012 | Substantially Equivalent | SEERS TECHNOLOGY CO, LTD |
| K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | Oct 22, 2012 | Substantially Equivalent | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
| K121372 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Sep 10, 2012 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K121932 | HEM-7200-Z (BP742) | Aug 29, 2012 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K121025 | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION | Aug 17, 2012 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K120320 | CONNECTED CARE CLINICAL APPLICATION | Aug 14, 2012 | Substantially Equivalent | WATERMARK MEDICAL INC |
| K120554 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Aug 10, 2012 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K120430 | MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P | Aug 02, 2012 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K112620 | DISITAL BLOOD PRESSURE MONITOR | Aug 02, 2012 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K121355 | WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Jul 18, 2012 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K120634 | U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM | Jul 03, 2012 | Substantially Equivalent | TaiDoc Technology Corporation |
| K121470 | FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR | Jun 14, 2012 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K120672 | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | Jun 01, 2012 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K113402 | SOLOHEALTH STATION | May 30, 2012 | Substantially Equivalent | SOLOHEALTH, INC. |
| K121141 | TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM | May 15, 2012 | Substantially Equivalent | TENSYS MEDICAL SYSTEMS, INC |
| K113239 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) | Mar 16, 2012 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | Mar 02, 2012 | Substantially Equivalent | LD TECHNOLOGY LLC |
| K113238 | FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR | Mar 01, 2012 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K112691 | BLOOD PRESSURE MONITOR | Feb 24, 2012 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K112690 | BLOOD PRESSURE MONITOR | Feb 24, 2012 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K111141 | BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR | Feb 21, 2012 | Substantially Equivalent | WENZHOU BOKANG INSTRUMENTS CO., LTD. |
| K120144 | VITAL SIGNS MONITOR | Feb 14, 2012 | Substantially Equivalent | EDAN INSTRUMENTS INC |
| K120132 | SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR | Feb 14, 2012 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K112042 | KINGYIELD WRIST BLOOD PRESSURE MONITOR | Feb 10, 2012 | Substantially Equivalent | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
| K120058 | TRANSTEK BLOOD PRESSURE MONITOR | Jan 31, 2012 | Substantially Equivalent | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
| K113185 | MODEL HBP-1300 | Jan 27, 2012 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K113083 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR | Jan 19, 2012 | Substantially Equivalent | TRULY INSTRUMENT CO., LTD. |
| K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | Jan 18, 2012 | Substantially Equivalent | AVITA CORPORATION |
| K113085 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR | Jan 12, 2012 | Substantially Equivalent | TRULY INSTRUMENT CO., LTD. |
| K112216 | U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM | Dec 22, 2011 | Substantially Equivalent | TaiDoc Technology Corporation |
| K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | Dec 21, 2011 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K112274 | U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM | Dec 21, 2011 | Substantially Equivalent | TaiDoc Technology Corporation |
| K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | Dec 16, 2011 | Substantially Equivalent | I.E.M. GMBH |
| K111830 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO | Dec 09, 2011 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K111826 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Dec 09, 2011 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K112845 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Dec 05, 2011 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K112647 | BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM | Nov 22, 2011 | Substantially Equivalent | WISTRON CORPORATION |
| K112273 | ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR | Nov 22, 2011 | Substantially Equivalent | ACCUMED HEALTHCARE (SHANGHAI) INC. |
| K112270 | ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR | Nov 22, 2011 | Substantially Equivalent | ACCUMED HEALTHCARE (SHANGHAI) INC. |
| K110770 | HEALTHTRACKER | Nov 16, 2011 | Substantially Equivalent | WISTRON CORPORATION |
| K103058 | MULTIFUNCTION KEITO | Nov 10, 2011 | Substantially Equivalent | AGUIFLAI IBERICA S.L. |
| K112269 | OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE | Oct 20, 2011 | Substantially Equivalent | OSTAR MEDITECH CORP. |
| K112652 | SURESIGNS VS2+ -SURESIGNS VSI | Oct 11, 2011 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K112320 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Sep 30, 2011 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | Aug 01, 2011 | Substantially Equivalent | A&D COMPANY, LTD. |
| K110156 | AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, | Jul 27, 2011 | Substantially Equivalent | CONTEC MEDICAL SYSTEM CO., LTD. |
| K111652 | MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR | Jul 13, 2011 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K110044 | FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM | Jul 07, 2011 | Substantially Equivalent | FORA CARE INC. |
| K101681 | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | May 27, 2011 | Substantially Equivalent | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
| K111114 | SURESIGNS VS2 VITAL SIGNS MONITOR | May 20, 2011 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | May 20, 2011 | Substantially Equivalent | WITHINGS |
| K110803 | SURESIGNS VSI VITAL SIGNS MONITOR | May 20, 2011 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K110775 | ELECTRONIC SPHYGMOMANOMETER | May 13, 2011 | Substantially Equivalent | CONTEC MEDICAL SYSTEMS CO., LTD. |
| K110774 | ELECTRONIC SPHYGMOMANOMETER | May 13, 2011 | Substantially Equivalent | CONTEC MEDICAL SYSTEM CO., LTD. |
| K110501 | HEM-4030 | Mar 21, 2011 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K110299 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES | Mar 21, 2011 | Substantially Equivalent | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
| K110018 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Mar 15, 2011 | Substantially Equivalent | ANDON HEALTH CO., LTD |
| K102939 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 | Feb 23, 2011 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K110330 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Feb 18, 2011 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102968 | INFINITY CNAP SMARTPOD | Feb 18, 2011 | Substantially Equivalent | Draeger Medical Systems, Inc. |
| K103693 | VANTAGE ABI | Feb 15, 2011 | Substantially Equivalent | SUMMIT DOPPLER SYSTEMS, INC. |
| K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR | Feb 04, 2011 | Substantially Equivalent | SPACELABS HEALTHCARE LTD. |
| K103046 | HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE | Jan 10, 2011 | Substantially Equivalent | HOSMAN INTERNATIONAL CO., LTD |
| K102624 | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | Dec 16, 2010 | Substantially Equivalent | AVITA CORPORATION |
| K102609 | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Dec 09, 2010 | Substantially Equivalent | ANDON MEDICAL CO., LTD. |
| K102690 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Nov 24, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102988 | ELECTRONIC BLOOD PRESURE MONITOR | Nov 09, 2010 | Substantially Equivalent | SHENZHEN PANGO ELECTRONIC CO., LTD |
| K102631 | KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Nov 04, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102930 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Nov 03, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102906 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Oct 29, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K101123 | NEXFIN MODEL 2 | Oct 28, 2010 | Substantially Equivalent | BMEYE B.V. |
| K102920 | ELECTRONIC BLOOD PRESSURE MONITOR | Oct 15, 2010 | Substantially Equivalent | SHENZHEN PANGO ELECTRONIC CO., LTD |
| K102356 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 | Sep 20, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102353 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 | Sep 17, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K102303 | BLOOD PRESSURE METER, MODEL CH-658 | Sep 10, 2010 | Substantially Equivalent | CITIZEN SYSTEMS JAPAN CO., LTD. |
| K101950 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 | Aug 31, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K100055 | BLOOD PRESSURE METER, MODEL CH-609 | Aug 30, 2010 | Substantially Equivalent | CITIZEN SYSTEMS JAPAN CO., LTD. |
| K100763 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 | Aug 27, 2010 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K101198 | CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K | Aug 04, 2010 | Substantially Equivalent | COMPUTERIZED SCREENING, INC. |
| K101010 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 | Jul 30, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093981 | YRNSORTIP OXIMANOMETER | Jul 22, 2010 | Substantially Equivalent | Cnoga Medical LTD |
| K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | Jul 09, 2010 | Substantially Equivalent | WELCH ALLYN, INC. |
| K100658 | U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM | Jul 09, 2010 | Substantially Equivalent | TaiDoc Technology Corporation |
| K100620 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 | Jul 02, 2010 | Substantially Equivalent | HARVARD MEDICAL DEVICES LTD. |
| K101512 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). | Jul 01, 2010 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K100940 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | Jun 29, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093931 | BLOOD PRESSURE METER, MODEL CH-4532 | Jun 10, 2010 | Substantially Equivalent | CITIZEN SYSTEMS JAPAN CO., LTD. |
| K101002 | A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 | Jun 08, 2010 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K093102 | AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 | Jun 03, 2010 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K101275 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). | May 28, 2010 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K100913 | IQVITALS AND IQVITALS SYSTEM | May 26, 2010 | Substantially Equivalent | BRENTWOOD MEDICAL TECHNOLOGY CORP. |
| K100553 | BLOOD PRESSURE METER MODEL CH-101 | May 25, 2010 | Substantially Equivalent | CITIZEN SYSTEMS JAPAN CO., LTD. |
| K093739 | BLOOD PRESSURE MONITOR/ MODELS | May 07, 2010 | Substantially Equivalent | NINGBO DIAIER ELECTRONIC CO., LTD. |
| K093907 | WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE | Apr 14, 2010 | Substantially Equivalent | WELCH ALLYN, INC. |
| K093802 | ULTRAVIEW DM3 MONITOR | Apr 09, 2010 | Substantially Equivalent | ZOE MEDICAL, INC. |
| K093205 | PADCHECK | Apr 01, 2010 | Substantially Equivalent | PADTEST, LLC |
| K092061 | FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 | Mar 26, 2010 | Substantially Equivalent | GENEXEL MEDICAL INSTRUMENT INC |
| K093831 | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT | Mar 25, 2010 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K092558 | WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES | Mar 17, 2010 | Substantially Equivalent | HARVARD MEDICAL DEVICES LTD. |
| K093824 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT | Feb 16, 2010 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K100014 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 | Jan 29, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K092106 | U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 | Jan 25, 2010 | Substantially Equivalent | TaiDoc Technology Corporation |
| K093823 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM | Jan 22, 2010 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K092893 | TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES | Jan 14, 2010 | Substantially Equivalent | TYTAN MEDICAL CORP. |
| K092811 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 | Jan 13, 2010 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093013 | BLOOD PRESSURE MONITOR, MODEL MD200A | Jan 08, 2010 | Substantially Equivalent | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
| K092588 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 | Dec 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093452 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 | Dec 23, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K092510 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 | Dec 23, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093528 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 | Dec 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K092514 | UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES | Dec 04, 2009 | Substantially Equivalent | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
| K093387 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 | Nov 27, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K093359 | 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 | Nov 27, 2009 | Substantially Equivalent | SHANGHAI LITTLE DOCTOR CO. LIMITED |
| K093389 | CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK | Nov 17, 2009 | Substantially Equivalent | COMPUTERIZED SCREENING, INC. |
| K092163 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB | Nov 16, 2009 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K092456 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C | Oct 23, 2009 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K091414 | VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH | Oct 21, 2009 | Substantially Equivalent | BIOCARE CORP. |
| K092806 | AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 | Oct 09, 2009 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K092432 | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) | Oct 09, 2009 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K092161 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF | Sep 30, 2009 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K092683 | DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 | Sep 25, 2009 | Substantially Equivalent | SHANGHAI LITTLE DOCTOR CO. LIMITED |
| K091553 | BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE | Sep 21, 2009 | Substantially Equivalent | NINGBO DIAIER ELECTRONIC CO., LTD. |
| K092719 | DIGITAL BLOOD PRESSURE MONITOR | Sep 18, 2009 | Substantially Equivalent | SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD |
| K091434 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M | Sep 04, 2009 | Substantially Equivalent | TRULY INSTRUMENT CO., LTD. |
| K091415 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M | Sep 04, 2009 | Substantially Equivalent | TRULY INSTRUMENT CO., LTD. |
| K091897 | BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 | Aug 25, 2009 | Substantially Equivalent | TaiDoc Technology Corporation |
| K091821 | COMMANDER 111, MODEL CD300-CD399 | Aug 25, 2009 | Substantially Equivalent | CARDIOCOM LLC |
| K091739 | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 | Aug 18, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K091738 | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD | Aug 18, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K091737 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 | Aug 18, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K091500 | MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | Jul 31, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K092045 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 | Jul 30, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K091997 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 | Jul 30, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083753 | SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU | Jun 19, 2009 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K090772 | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 | Jun 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090771 | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 | Jun 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090770 | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 | Jun 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090769 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 | Jun 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090768 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, | Jun 04, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K091068 | ACCUTORR V MONITOR, MODEL 0998-00-2000 | May 08, 2009 | Substantially Equivalent | DATASCOPE CORP., PATIENT MONITORING DIVISION |
| K090963 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | Apr 30, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090058 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB | Apr 22, 2009 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K083395 | SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 | Feb 27, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K090027 | BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 | Feb 02, 2009 | Substantially Equivalent | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
| K083319 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083318 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083317 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083248 | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083247 | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083246 | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 | Jan 29, 2009 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K083681 | BIOLAND BLOOD PRESSURE MONITOR | Jan 16, 2009 | Substantially Equivalent | BIOLAND TECHNOLOGY LTD. |
| K081924 | CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE | Jan 07, 2009 | Substantially Equivalent | CALHEALTH INC |
| K081498 | TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 | Dec 17, 2008 | Substantially Equivalent | BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
| K081852 | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 | Dec 12, 2008 | Substantially Equivalent | TRULY INSTRUMENT LIMITED |
| K083078 | QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 | Nov 26, 2008 | Substantially Equivalent | QUANTA COMPUTER INC. |
| K082881 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 | Nov 24, 2008 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | Nov 13, 2008 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K082357 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). | Oct 29, 2008 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K083043 | KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 | Oct 27, 2008 | Substantially Equivalent | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
| K082599 | NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT | Oct 17, 2008 | Substantially Equivalent | CNSYSTEM MEDIZINTECHNIK AG |
| K081654 | HEM-9000AI | Oct 10, 2008 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K081159 | HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES | Aug 08, 2008 | Substantially Equivalent | HARVARD MEDICAL DEVICES LTD. |
| K080326 | KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Jul 31, 2008 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K072109 | STATMAP, MODEL 7200 | Jul 31, 2008 | Substantially Equivalent | RAMSEY MEDICAL, INC. |
| K080319 | KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Jul 02, 2008 | Substantially Equivalent | ANDON HEALTH CO.,LTD |
| K081590 | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J | Jun 19, 2008 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K080337 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D | May 13, 2008 | Substantially Equivalent | MICROLIFE CORP. |
| K080177 | WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV | May 09, 2008 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K080274 | AMBULO 2400 | Apr 23, 2008 | Substantially Equivalent | TIBA MEDICAL, INC. |
| K080789 | BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 | Apr 03, 2008 | Substantially Equivalent | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
| K073445 | CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 | Apr 02, 2008 | Substantially Equivalent | TaiDoc Technology Corporation |
| K080289 | 1500 PRO | Feb 26, 2008 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K072860 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 | Feb 25, 2008 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K073630 | MODIFICATION TO: BPCARD, MODEL Z-7000-0700 | Jan 11, 2008 | Substantially Equivalent | QRS DIAGNOSTIC, LLC. |
| K073198 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) | Jan 11, 2008 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) | Dec 20, 2007 | Substantially Equivalent | MICROLIFE CORP. |
| K073397 | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) | Dec 20, 2007 | Substantially Equivalent | MICROLIFE CORP. |
| K072137 | AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB | Dec 07, 2007 | Substantially Equivalent | AVITA CORPORATION |
| K072446 | MOBIL-O-GRAPH NG 24 H ABP-CONTROL | Nov 29, 2007 | Substantially Equivalent | I.E.M. GMBH |
| K072049 | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | Nov 29, 2007 | Substantially Equivalent | BMEYE B.V. |
| K072593 | A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE | Nov 15, 2007 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K071384 | MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 | Oct 09, 2007 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K072272 | HONEYWELL HOMMED CENTRAL STATION 4.0 | Sep 07, 2007 | Substantially Equivalent | HONEYWELL HOMMED, LLC |
| K070828 | KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Aug 15, 2007 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K070826 | KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | Aug 15, 2007 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K062974 | TESLA NIBP | Aug 13, 2007 | Substantially Equivalent | MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH |
| K070209 | FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR | Aug 08, 2007 | Substantially Equivalent | FEGO PRECISION INDUSTRIAL CO; LTD |
| K071960 | MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 | Aug 03, 2007 | Substantially Equivalent | MEDITECH KFT. |
| K071523 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 | Jun 26, 2007 | Substantially Equivalent | GENEXEL-SEIN, INC. |
| K070395 | KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Jun 07, 2007 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K063008 | HEALTH CHECK KIOSK | Jun 07, 2007 | Substantially Equivalent | XPEREX CORPORATION |
| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | May 25, 2007 | Substantially Equivalent | TERUMO CORP. |
| K070825 | LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR | May 25, 2007 | Substantially Equivalent | LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING |
| K070473 | BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX | May 23, 2007 | Substantially Equivalent | ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
| K070086 | SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR | May 10, 2007 | Substantially Equivalent | SENSACARE LTD. |
| K070750 | 247 BP DEVICE | May 02, 2007 | Substantially Equivalent | SUNTECH MEDICAL, INC. |
| K063137 | PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 | May 01, 2007 | Substantially Equivalent | PHARMASMART, INC. |
| K062033 | BP 101 DIGITAL BLOOD PRESSURE MONITOR | Mar 23, 2007 | Substantially Equivalent | KING YIELD HONGKONG LIMITED |
| K063814 | BP-200 PLUS | Mar 07, 2007 | Substantially Equivalent | SCHILLER AG |
| K062893 | KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A | Feb 05, 2007 | Substantially Equivalent | SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. |
| K063111 | FINOMETER MODEL-2 WITH ACCESSORIES | Feb 01, 2007 | Substantially Equivalent | FINAPRES MEDICAL SYSTEMS BV |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | Jan 19, 2007 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K061935 | SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR | Nov 08, 2006 | Substantially Equivalent | SENSACARE LTD. |
| K062462 | NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L | Sep 29, 2006 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K061557 | FUSION | Sep 15, 2006 | Substantially Equivalent | MEDWAVE, INC. |
| K061471 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC | Sep 11, 2006 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K061959 | MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 | Aug 22, 2006 | Substantially Equivalent | MYTECH TECHNOLOGY CO., LTD. |
| K061279 | LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Aug 18, 2006 | Substantially Equivalent | LITTLE DOCTOR (SHANGHAI) ELECTRONIC |
| K061760 | ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 | Aug 14, 2006 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K061086 | DM-3000 DIGITAL BLOOD PRESSURE MONITOR | Aug 10, 2006 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 | Aug 02, 2006 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K061452 | TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM | Jul 12, 2006 | Substantially Equivalent | TUNG FU ELECTRIC CO., LTD. |
| K061558 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U | Jun 29, 2006 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K061161 | BLOOD PRESSURE METER, MODEL CH-311B | Jun 26, 2006 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | Jun 21, 2006 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K061403 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U | Jun 14, 2006 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K060686 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC | Jun 09, 2006 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMBH |
| K060820 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 | Jun 07, 2006 | Substantially Equivalent | SUNTECH MEDICAL, INC. |
| K061073 | CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 | Jun 02, 2006 | Substantially Equivalent | TaiDoc Technology Corporation |
| K060925 | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 | May 09, 2006 | Substantially Equivalent | ACON LABORATORIES, INC. |
| K053453 | HOMMED CENTRAL STATION, VERSION 3.5 | May 05, 2006 | Substantially Equivalent | HONEYWELL HOMMED LLC |
| K060835 | HL888SF | Apr 21, 2006 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K060729 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV | Apr 12, 2006 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K060315 | HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Apr 07, 2006 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K060703 | PMP4 BP PRO BLOOD PRESSURE MONITOR | Apr 04, 2006 | Substantially Equivalent | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
| K060342 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K | Apr 04, 2006 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K060504 | IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 | Mar 14, 2006 | Substantially Equivalent | IDEAL LIFE INC. |
| K060077 | RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A | Mar 08, 2006 | Substantially Equivalent | REAL TONE TECHNOLOGY CORP. |
| K052450 | KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | Feb 28, 2006 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K052676 | KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Feb 17, 2006 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K060194 | MARCH HEALTHCARE HEALTH MONITORING KIT | Feb 13, 2006 | Substantially Equivalent | MARCH HEALTHCARE CORPORATION |
| K052671 | HOCA EZ-CARE BP108, TENDER-CARE BP109 | Feb 03, 2006 | Substantially Equivalent | HOCA MEDICAL MICROSYSTEM, INC. |
| K053185 | PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | Jan 24, 2006 | Substantially Equivalent | MEDWAVE, INC. |
| K053209 | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM | Jan 05, 2006 | Substantially Equivalent | SUNTECH MEDICAL, INC. |
| K051847 | KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | Jan 05, 2006 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K053304 | COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM | Dec 30, 2005 | Substantially Equivalent | CARDIOCOM LLC |
| K053303 | CARDIOCOM COMMANDER III | Dec 30, 2005 | Substantially Equivalent | CARDIOCOM LLC |
| K051903 | FETALGARD LITE-NIBP, MODEL FGL-NIBP | Dec 27, 2005 | Substantially Equivalent | ANALOGIC CORPORATION |
| K053395 | BP PRO BLOOD PRESSURE MONITOR | Dec 23, 2005 | Substantially Equivalent | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
| K052727 | ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 | Dec 16, 2005 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K052872 | IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A | Nov 23, 2005 | Substantially Equivalent | TaiDoc Technology Corporation |
| K052784 | DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 | Nov 22, 2005 | Substantially Equivalent | WELCH ALLYN, INC. |
| K051149 | MEDITECH MODEL ABPM-04 | Nov 18, 2005 | Substantially Equivalent | MEDITECH KFT. |
| K050233 | OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI | Oct 28, 2005 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K052046 | BLOOD PRESSURE METER, MODEL CH-432 | Oct 19, 2005 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K051366 | PICONIBP OEM MODULE | Sep 14, 2005 | Substantially Equivalent | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
| K051565 | PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA | Sep 12, 2005 | Substantially Equivalent | PROTON HEALTHCARE LTD. |
| K052154 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC | Sep 08, 2005 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K052153 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL | Sep 08, 2005 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K051862 | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. | Aug 23, 2005 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K051863 | AMLUCK, YA HORNG | Aug 19, 2005 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K051703 | CLEVER TD-3018A BLOOD PRESSURE MONITOR | Aug 12, 2005 | Substantially Equivalent | TaiDoc Technology Corporation |
| K051368 | BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM | Aug 09, 2005 | Substantially Equivalent | SCHILLER AG |
| K051375 | VITAL SIGNS MONITOR | Jul 28, 2005 | Substantially Equivalent | MEDIANA CO., LTD. |
| K051106 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS | Jul 01, 2005 | Substantially Equivalent | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
| K051546 | BPCALIBRATOR MC3000/MC3100 | Jun 24, 2005 | Substantially Equivalent | HEALTHSTATS INTERNATIONAL PTE. LTD. |
| K050680 | BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 | May 13, 2005 | Substantially Equivalent | OSTAR MEDITECH CORP. |
| K043531 | MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 | Apr 21, 2005 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K050083 | BLOOD-PRESSURE METER, BPW120 | Apr 08, 2005 | Substantially Equivalent | IDT TECHNOLOGY LIMITED |
| K050714 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS | Apr 07, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K050711 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT | Apr 07, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K050587 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM | Apr 05, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K042506 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M | Apr 05, 2005 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K042505 | OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N | Apr 05, 2005 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K050491 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF | Mar 31, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K043352 | GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR | Mar 31, 2005 | Substantially Equivalent | GOCANNING TECHNOLOGY LTD. |
| K050249 | HL168JP | Mar 30, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K050040 | MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR | Mar 30, 2005 | Substantially Equivalent | MARS MEDICAL PRODUCTS |
| K050697 | MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR | Mar 25, 2005 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K050039 | MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR | Mar 25, 2005 | Substantially Equivalent | MARS MEDICAL PRODUCTS |
| K042418 | KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Mar 21, 2005 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K042109 | DIASYS INTEGRA II | Mar 09, 2005 | Substantially Equivalent | NOVACOR FRANCE |
| K050413 | AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 | Mar 04, 2005 | Substantially Equivalent | AMPLIFE CORPORATION |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | Mar 03, 2005 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K042768 | MEDICOMPASS CONNECT | Feb 22, 2005 | Substantially Equivalent | IMETRIKUS, INC. |
| K043550 | AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 | Jan 27, 2005 | Substantially Equivalent | AMPLIFE CORPORATION |
| K042818 | PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037 | Jan 27, 2005 | Substantially Equivalent | MATSUSHITA ELECTRIC WORKS, LTD. |
| K043437 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET | Jan 12, 2005 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K032825 | VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR | Dec 10, 2004 | Substantially Equivalent | MARS MEDICAL PRODUCTS CO., LTD. |
| K043186 | H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM | Dec 06, 2004 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | Dec 03, 2004 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K041693 | WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES | Dec 02, 2004 | Substantially Equivalent | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
| K043096 | COMMANDER II | Nov 24, 2004 | Substantially Equivalent | CARDIOCOM |
| K043018 | OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 | Nov 10, 2004 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K042853 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA | Nov 10, 2004 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K042802 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q | Oct 26, 2004 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K042581 | AMLUCK, YA HORNG | Oct 13, 2004 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K041854 | MPM SYSTEM | Oct 06, 2004 | Substantially Equivalent | AEROTEL MEDICAL SYSTEMS, LTD. |
| K041491 | ZEWA MFM-007 BLOOD PRESSURE MONITOR | Sep 20, 2004 | Substantially Equivalent | ZEWA, INC. |
| K042273 | MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY | Aug 31, 2004 | Substantially Equivalent | HEALTH HERO NETWORK, INC. |
| K042265 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 | Aug 31, 2004 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K041778 | REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T | Aug 31, 2004 | Substantially Equivalent | MAXI-AIDS, INC. |
| K040562 | LIFECLINIC, MODEL 2400 | Aug 31, 2004 | Substantially Equivalent | LIFECLINIC INTERNATIONAL, INC. |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | Aug 24, 2004 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K041400 | FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 | Aug 24, 2004 | Substantially Equivalent | FORTIFIER INTERNATIONAL CO., LTD. |
| K041169 | PIESOMETER, MODEL MK-1 | Aug 24, 2004 | Substantially Equivalent | CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. |
| K040799 | HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS | Aug 18, 2004 | Substantially Equivalent | HOMMED LLC. |
| K040490 | WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE | Aug 18, 2004 | Substantially Equivalent | WELCH ALLYN, INC. |
| K040651 | HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM | Aug 10, 2004 | Substantially Equivalent | HOMMED LLC. |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 | Aug 06, 2004 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K041411 | MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP | Jul 21, 2004 | Substantially Equivalent | MICROLIFE CORP. |
| K041789 | NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T | Jul 15, 2004 | Substantially Equivalent | MEDITEC CO., LTD. |
| K041313 | STABIL-O-GRAPH | Jun 18, 2004 | Substantially Equivalent | I.E.M. GMBH |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | May 19, 2004 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K041228 | MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 | May 17, 2004 | Substantially Equivalent | MYTECH TECHNOLOGY CO., LTD. |
| K031327 | VERICOR | May 12, 2004 | Substantially Equivalent | CVP DIAGNOSTICS, INC. |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | May 07, 2004 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K040410 | GREENLIGHT 300 | May 05, 2004 | Substantially Equivalent | A C COSSOR & SON (SURGICAL) LIMITED |
| K033216 | BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR | May 04, 2004 | Substantially Equivalent | THE BUZZ GROUP, LLC |
| K040528 | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T | Apr 15, 2004 | Substantially Equivalent | YA HORNG ELECTRONIC CO., LTD. |
| K033397 | AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY | Apr 09, 2004 | Substantially Equivalent | AVITA CORPORATION |
| K040012 | WELL@HOME SYSTEM | Apr 02, 2004 | Substantially Equivalent | ZOE MEDICAL, INC. |
| K040159 | APM BLOOD PRESSURE MONITOR, MODEL BP108A | Mar 22, 2004 | Substantially Equivalent | ASIA PACIFIC MICROSYSTEMS, INC. |
| K040002 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 | Mar 22, 2004 | Substantially Equivalent | MICROLIFE INTELLECTUAL PROPERTY GMB |
| K031487 | MODEL AVANT 2120 PULSE OXIMETER AND NIBP | Mar 22, 2004 | Substantially Equivalent | NONIN MEDICAL, INC. |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | Mar 19, 2004 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K033894 | PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 | Mar 11, 2004 | Substantially Equivalent | MATSUSHITA ELECTRIC WORKS, LTD. |
| K040086 | HEALTH BUDDY WITH BUDDYLINK | Mar 10, 2004 | Substantially Equivalent | HEALTH HERO NETWORK, INC. |
| K040032 | CENTRAL STATION, VERSION 3.3H | Feb 27, 2004 | Substantially Equivalent | HOMMED LLC. |
| K040309 | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 | Feb 24, 2004 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K032305 | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL | Feb 11, 2004 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K032857 | PRESS-MATE BX-10 VITAL SIGN MONITOR | Feb 04, 2004 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K033025 | TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700 | Dec 10, 2003 | Substantially Equivalent | TYTAN MEDICAL CORP. |
| K032308 | BLOOD PRESSURE MONITOR, MODEL M100 | Nov 10, 2003 | Substantially Equivalent | MEDITEK TECHNOLOGY, INC. |
| K030359 | KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Nov 06, 2003 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K032363 | ZOLL M SERIES NIBP OPTION | Oct 31, 2003 | Substantially Equivalent | ZOLL MEDICAL CORP. |
| K030358 | KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Oct 31, 2003 | Substantially Equivalent | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | Oct 30, 2003 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K023723 | FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 | Oct 23, 2003 | Substantially Equivalent | FMS, FINAPRES MEDICAL SYSTEMS BV |
| K033043 | MODIFICATION TO HL168 | Oct 10, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K032839 | HL888BA | Oct 10, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K032837 | HL888BM | Oct 10, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K031840 | CAREMATIX WELLNESS SYSTEM | Oct 10, 2003 | Substantially Equivalent | CAREMATIX INC. |
| K032913 | HL888 AF | Oct 02, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K032695 | HL888BF | Oct 02, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K032492 | BLOOD PRESSURE MONITOR, MODEL KP-7000 | Sep 09, 2003 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K031964 | BPCARD | Sep 05, 2003 | Substantially Equivalent | QRS DIAGNOSTIC, LLC. |
| K030221 | MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR | Jul 25, 2003 | Substantially Equivalent | MYTECH TECHNOLOGY CO., LTD. |
| K031835 | HL888RA | Jul 01, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K031695 | HL168R | Jul 01, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K031479 | AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 | Jun 06, 2003 | Substantially Equivalent | DATEX-OHMEDA, INC. |
| K022926 | GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 | Jun 06, 2003 | Substantially Equivalent | GENTEEL TECHNOLOGY CO., LTD. |
| K030230 | AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) | May 23, 2003 | Substantially Equivalent | AVITA CORPORATION |
| K030561 | MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A | May 09, 2003 | Substantially Equivalent | MYTECH TECHNOLOGY CO., LTD. |
| K023338 | PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 | May 09, 2003 | Substantially Equivalent | FMS, FINAPRES MEDICAL SYSTEMS BV |
| K023286 | CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION | May 02, 2003 | Substantially Equivalent | NEPTEC DESIGN GROUP, LTD. |
| K030541 | HL888JF | Apr 24, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K030499 | HL888HM | Apr 17, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K030498 | HL888HA | Apr 11, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K030825 | MPM-NET | Mar 28, 2003 | Substantially Equivalent | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
| K023078 | BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR | Mar 21, 2003 | Substantially Equivalent | VSM MEDTECH LTD. |
| K024077 | DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR | Mar 10, 2003 | Substantially Equivalent | ZEWA, INC. |
| K024005 | WELCH ALLYN VITAL SIGN MONITOR WITH MP506 | Feb 12, 2003 | Substantially Equivalent | WELCH ALLYN, INC. |
| K023834 | HL888 | Jan 14, 2003 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K021682 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC | Dec 12, 2002 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K022916 | BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 | Nov 21, 2002 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K022783 | TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM | Nov 19, 2002 | Substantially Equivalent | TENSYS MEDICAL, INC. |
| K021240 | EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 | Nov 08, 2002 | Substantially Equivalent | EIKON HEALTHCARE DEVICE CORP. |
| K021239 | EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M | Nov 08, 2002 | Substantially Equivalent | EIKON HEALTHCARE DEVICE CORP. |
| K023495 | WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) | Oct 31, 2002 | Substantially Equivalent | WELCH ALLYN, INC. |
| K023055 | BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 | Oct 22, 2002 | Substantially Equivalent | VSM MEDTECH LTD. |
| K014141 | DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 | Sep 13, 2002 | Substantially Equivalent | DIGIBIO TECHNOLOGY CORP. |
| K020537 | TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM | Aug 15, 2002 | Substantially Equivalent | TENSYS MEDICAL, INC. |
| K020897 | ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400 | Aug 06, 2002 | Substantially Equivalent | ROSSMAX INTERNATIONL LTD. |
| K013434 | VP-2000/1000 | Jul 09, 2002 | Substantially Equivalent | COLIN CORP. |
| K021305 | MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER | Jun 28, 2002 | Substantially Equivalent | MICROLIFE CORP. |
| K021756 | WELCH ALLYN ABPM 6100 | Jun 27, 2002 | Substantially Equivalent | WELCH ALLYN, INC. |
| K021252 | BLOOD-PRESSURE METER | Jun 17, 2002 | Substantially Equivalent | IDT TECHNOLOGY LIMITED |
| K021447 | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM | May 22, 2002 | Substantially Equivalent | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
| K021225 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I | May 22, 2002 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K020584 | N2000 BASE STATION; N2001 NURSE STATION | May 22, 2002 | Substantially Equivalent | NEPTEC DESIGN GROUP, LTD. |
| K020184 | HOMMED CENTRAL STATION | Apr 22, 2002 | Substantially Equivalent | HOMMED LLC. |
| K021029 | ABP-2000 G-3 | Apr 12, 2002 | Substantially Equivalent | BIOTRAC, INC. |
| K020766 | HL168F | Apr 05, 2002 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K012796 | AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 | Mar 14, 2002 | Substantially Equivalent | AMLUCK, INC. |
| K014204 | ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 | Mar 05, 2002 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K012487 | SPHYGMOCOR PX MODEL SCOR-PX | Feb 21, 2002 | Substantially Equivalent | ATCOR MEDICAL PTY. LTD |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | Feb 15, 2002 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K011625 | VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) | Jan 23, 2002 | Substantially Equivalent | VASOCOR, INC. |
| K013583 | ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS | Jan 17, 2002 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K013539 | ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS | Jan 17, 2002 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K013485 | MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 | Jan 17, 2002 | Substantially Equivalent | MICROLIFE CORP. |
| K014122 | HL168E | Jan 16, 2002 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K013478 | DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM | Jan 10, 2002 | Substantially Equivalent | PULSE METRIC, INC. |
| K013358 | DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM | Dec 13, 2001 | Substantially Equivalent | PULSE METRIC, INC. |
| K012801 | N2000 BASE STATION, N2001 NURSE STATION | Nov 14, 2001 | Substantially Equivalent | NEPTEC DESIGN GROUP, LTD. |
| K012647 | TONOPORT V | Nov 09, 2001 | Substantially Equivalent | PAR MEDIZINTECHNIK GMBH |
| K012498 | DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM | Nov 01, 2001 | Substantially Equivalent | PULSE METRIC, INC. |
| K012636 | BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | Oct 26, 2001 | Substantially Equivalent | VSM TECHNOLOGY, INC. |
| K013033 | MODIFICATION TO: HL168W TOUCH SCREEN | Oct 23, 2001 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K011058 | TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII | Oct 23, 2001 | Substantially Equivalent | MERIDIAN MEDICAL TECHNOLOGIES LTD. |
| K012310 | MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR | Aug 22, 2001 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | Aug 08, 2001 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K012035 | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 | Jul 27, 2001 | Substantially Equivalent | BRAUN GMBH |
| K011539 | ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS | Jul 20, 2001 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K011352 | ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS | Jul 20, 2001 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K011310 | NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 | Jul 20, 2001 | Substantially Equivalent | NIEN MADE ELECTRNICS CORP. |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | Jul 13, 2001 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K011779 | AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM | Jul 13, 2001 | Substantially Equivalent | AVID CARE CORP. |
| K010029 | HOME HEALTH MONITORING SYSTEM | Jun 29, 2001 | Substantially Equivalent | AVID CARE CORP. |
| K003180 | HOMMED OBSERVER, MODEL I | Jun 28, 2001 | Substantially Equivalent | HOMMED LLC. |
| K011523 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 | Jun 14, 2001 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K010751 | BPFONE, MODEL UA 767IT | Jun 11, 2001 | Substantially Equivalent | MEDICAL MONITORS PTY LIMITED |
| K010186 | WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM | Jun 08, 2001 | Substantially Equivalent | WELCH ALLYN, INC. |
| K011152 | VASOTRAC APM205A | May 31, 2001 | Substantially Equivalent | MEDWAVE, INC. |
| K003732 | BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES | May 16, 2001 | Substantially Equivalent | BRAUN GMBH |
| K010828 | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP | Mar 29, 2001 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K010622 | PRESSURE TRAK, MODEL 222-B | Mar 29, 2001 | Substantially Equivalent | SUNTECH MEDICAL INSTRUMENTS, INC. |
| K010498 | WRISTWATCH BLOOD PRESSURE MONITOR A46 | Mar 20, 2001 | Substantially Equivalent | ROSSMAX INTERNATIONL LTD. |
| K002665 | WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 | Mar 19, 2001 | Substantially Equivalent | K-JUMP HEALTH CO., LTD. |
| K010190 | WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 | Feb 08, 2001 | Substantially Equivalent | ROSSMAX INTERNATIONL LTD. |
| K002791 | NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | Jan 29, 2001 | Substantially Equivalent | UNIX ELECTRONIC CO. LTD. |
| K001543 | BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 | Jan 29, 2001 | Substantially Equivalent | WELCH ALLYN, INC. |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | Dec 15, 2000 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K003444 | MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR | Nov 21, 2000 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K002530 | WELCH ALLYN SPOT CHECK DEVICE | Nov 14, 2000 | Substantially Equivalent | WELCH ALLYN, INC. |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | Nov 01, 2000 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K001948 | CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM | Nov 01, 2000 | Substantially Equivalent | HYPERTENSION DIAGNOSTICS, INC. |
| K003004 | OSCAR 2, MODEL 222 | Oct 25, 2000 | Substantially Equivalent | SUNTECH MEDICAL INSTRUMENTS, INC. |
| K002882 | HL168B | Oct 13, 2000 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K001244 | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D | Sep 26, 2000 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | Sep 21, 2000 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K002029 | ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION | Sep 21, 2000 | Substantially Equivalent | ZOLL MEDICAL CORP. |
| K002750 | HL168T | Sep 18, 2000 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K002722 | DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 | Sep 11, 2000 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K002655 | DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 | Sep 06, 2000 | Substantially Equivalent | MEDITEC CO., LTD. |
| K001898 | VASOTRAX | Aug 31, 2000 | Substantially Equivalent | MEDWAVE, INC. |
| K002388 | EHC500 DESKTOP PATIENT STATION, MODEL EHC500 | Aug 25, 2000 | Substantially Equivalent | CYBERCARE, INC. |
| K001182 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 | Aug 01, 2000 | Substantially Equivalent | MICROLIFE CORP. |
| K002115 | A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS | Jul 25, 2000 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K002046 | MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | Jul 21, 2000 | Substantially Equivalent | VSM TECHNOLOGY, INC. |
| K001848 | OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 | Jul 03, 2000 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K001671 | ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 | Jun 30, 2000 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K001670 | AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 | Jun 30, 2000 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K000237 | EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION | Jun 13, 2000 | Substantially Equivalent | CYBERCARE, INC. |
| K993316 | UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE | Jun 09, 2000 | Substantially Equivalent | UEDA AVANCER CORP. |
| K000500 | DINAMAP ADVANCED NIBP MODULE | May 26, 2000 | Substantially Equivalent | CRITIKON COMPANY, L.L.C. |
| K991458 | MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 | Apr 10, 2000 | Substantially Equivalent | MATSUSHITA ELECTRIC CORP. OF AMERICA |
| K994423 | AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | Mar 28, 2000 | Substantially Equivalent | VSM MEDTECH LTD. |
| K993938 | THE HOMMED SENTRY, MODEL 1 SENTRY | Mar 15, 2000 | Substantially Equivalent | HOMMED LLC. |
| K000675 | MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 | Mar 14, 2000 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K984083 | MULTIFUNCTION KEITO K5 | Jan 18, 2000 | Substantially Equivalent | BUMEDCO INTL., INC. |
| K993460 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 | Jan 11, 2000 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K993429 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 | Jan 07, 2000 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K993426 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 | Jan 07, 2000 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K993542 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 | Dec 29, 1999 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K993888 | A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS | Dec 20, 1999 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K993432 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 | Dec 20, 1999 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K990807 | HL148 & HL168 | Dec 03, 1999 | Substantially Equivalent | HEALTH & LIFE CO., LTD. |
| K993890 | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 | Dec 01, 1999 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K992478 | PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | Oct 15, 1999 | Substantially Equivalent | HEWLETT-PACKARD, HEALTHCARE SOLUTIONS GROUP |
| K983616 | DAIWA MODEL 180 | Oct 15, 1999 | Substantially Equivalent | DAIWA PRODUCTS, INC. |
| K990638 | ANEROID SPHYGMOMANOMETER | Oct 07, 1999 | Substantially Equivalent | GENMED, INC. |
| K983717 | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM | Sep 16, 1999 | Substantially Equivalent | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
| K992808 | A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE | Sep 01, 1999 | Substantially Equivalent | A&D MEDICAL DIV. |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Sep 01, 1999 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K990648 | KELLER VITAL SIGNS MONITOR, KMS 890+ | Aug 10, 1999 | Substantially Equivalent | KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
| K992328 | FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 | Jul 21, 1999 | Substantially Equivalent | MEDITEC CO., LTD. |
| K991688 | WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S | Jun 01, 1999 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K983575 | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX | May 13, 1999 | Substantially Equivalent | DATASCOPE CORP. |
| K984223 | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 | Apr 28, 1999 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K982641 | ADVANCED NIBP MODULE | Mar 29, 1999 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K984618 | BCI MINI-TORR PLUS, MODEL 6004 | Mar 25, 1999 | Substantially Equivalent | BCI INTL., INC. |
| K981702 | AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 | Mar 05, 1999 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K981542 | PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 | Mar 03, 1999 | Substantially Equivalent | PANASONIC CORPORATION (PANASONIC) |
| K981431 | PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 | Mar 03, 1999 | Substantially Equivalent | PANASONIC CORPORATION (PANASONIC) |
| K964235 | ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL | Mar 02, 1999 | Substantially Equivalent | INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI |
| K990380 | (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 | Feb 22, 1999 | Substantially Equivalent | MEDITEC CO., LTD. |
| K983796 | 6004 NIBP MONITOR WITH TEMPERATURE | Jan 22, 1999 | Substantially Equivalent | BCI INTL., INC. |
| K980845 | MS-900S, MS-900SPM & MS-900SFM | Dec 14, 1998 | Substantially Equivalent | MARS MEDICAL PRODUCTS |
| K983855 | FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F | Nov 17, 1998 | Substantially Equivalent | JAWON MEDICAL CO., LTD. |
| K982481 | A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR | Sep 25, 1998 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K973637 | PRESS-MATE ADVANTAGE | Sep 25, 1998 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K982135 | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 | Sep 15, 1998 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K964153 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 | Jun 11, 1998 | Substantially Equivalent | ROSSMAX INTERNATIONAL LTD. |
| K973613 | CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER | Apr 14, 1998 | Substantially Equivalent | FOLEY & LARDNER |
| K980824 | A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR | Mar 19, 1998 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K973061 | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) | Mar 13, 1998 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K972795 | CARDIO-CARD MANAGEMENT SYSTEM II | Feb 20, 1998 | Substantially Equivalent | NASIFF ASSOC., INC. |
| K974061 | RECHARGEABLE BATTERY PART NUMBER GL825-200 | Jan 16, 1998 | Substantially Equivalent | ALEXANDER MFG. CO. |
| K970629 | TANGO NON-INVASIVE BLOOD PRESSURE MONITOR | Jan 02, 1998 | Substantially Equivalent | SUNTECH MEDICAL INSTRUMENTS, INC. |
| K970801 | BCI MODEL 6004 NIBP MONITOR (6004) | Nov 12, 1997 | Substantially Equivalent | BCI INTL., INC. |
| K954547 | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER | Apr 01, 1997 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K961144 | MS-2000 | Mar 12, 1997 | Substantially Equivalent | TOURITU ENGINEERING CO., INC. |
| K964697 | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | Feb 11, 1997 | Substantially Equivalent | ADVANCE MEDICAL DEVICE, INC. |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | Nov 14, 1996 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K952826 | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 | Nov 14, 1996 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K952882 | PERSONAL TELEMEDICINE SYSTEM | Sep 09, 1996 | Substantially Equivalent | AMERICAN TELECARE, INC. |
| K952979 | HANC NETWORK | Jul 25, 1996 | Substantially Equivalent | HEALTHTECH SERVICES CORP. |
| K960319 | A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR | Jul 02, 1996 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K955342 | OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER | Jun 17, 1996 | Substantially Equivalent | RASHMAN CORP. |
| K951193 | CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 | Mar 13, 1996 | Substantially Equivalent | TYCOS INSTRUMENTS, INC. |
| K945215 | MARS DIGITAL BLOOD PRESSURE MONITOR | Jan 31, 1996 | Substantially Equivalent | MARS METAL CO., LTD. |
| K952494 | DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR | Dec 28, 1995 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K945138 | OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS | Nov 20, 1995 | Substantially Equivalent | INVIVO RESEARCH, INC. |
| K951977 | DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 | Oct 24, 1995 | Substantially Equivalent | INTEGRATED DISPLAY TECHNOLOGY, LTD. |
| K953472 | NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR | Oct 20, 1995 | Substantially Equivalent | NELLCOR, INC. |
| K942543 | ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS | Jul 14, 1995 | Substantially Equivalent | SANKEI CO., LTD. |
| K945111 | DYNAPULSE 5000A (DP5000A) | Jun 23, 1995 | Substantially Equivalent | PULSE METRIC, INC. |
| K942072 | MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND | May 10, 1995 | Substantially Equivalent | MABIS HEALTHCARE, INC. |
| K945947 | NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER | Mar 08, 1995 | Substantially Equivalent | NELLCOR, INC. |
| K942423 | NAIS WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent | KING & SPALDING |
| K942422 | PANASONIC WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent | KING & SPALDING |
| K950249 | VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205 | Feb 01, 1995 | Substantially Equivalent | MEDWAVE, INC. |
| K943081 | TRIMLINE 2000 | Jan 27, 1995 | Substantially Equivalent | PYMAH CORP. |
| K942546 | CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER | Jan 27, 1995 | Substantially Equivalent | DYNATECH/NEVADA, INC. |
| K942163 | WINNER SELF-TAKING HOME BLOOD PRESSURE KIT | Dec 20, 1994 | Substantially Equivalent | WINMED INSTRUMENTS MFG. CORP. |
| K942649 | MINIMUS I; MINIMUS III, SANAPHON | Nov 29, 1994 | Substantially Equivalent | RUD RIESTER GMBH & CO KG |
| K941490 | BLOOD PRESSURE METER MODEL NO. BPM888 | Nov 29, 1994 | Substantially Equivalent | INTEGRATED DISPLAY TECHNOLOGY, LTD. |
| K942336 | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Nov 28, 1994 | Substantially Equivalent | INTEGRATED DISPLAY TECHNOLOGY, LTD. |
| K941167 | NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553) | Nov 14, 1994 | Substantially Equivalent | SPACELABS MEDICAL, INC. |
| K942871 | PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM | Oct 17, 1994 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K942650 | BIG BEN | Aug 15, 1994 | Substantially Equivalent | RUD RIESTER GMBH & CO KG |
| K934385 | MINIPACK 3100/3000 MODIFICATION | Aug 10, 1994 | Substantially Equivalent | PACE TECH, INC. |
| K940620 | ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR | Aug 01, 1994 | Substantially Equivalent | QUALITY SYSTEMS DESIGN, INC. |
| K935782 | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES | Aug 01, 1994 | Substantially Equivalent | OHMEDA MEDICAL |
| K943461 | VARIOUS TYPES OF MERCURIALS | Jul 27, 1994 | Substantially Equivalent | RUD RIESTER GMBH & CO KG |
| K925295 | EXACTA-SPEZIAL | Mar 25, 1994 | Substantially Equivalent | RUDOLF RIESTER GMBH & CO. KG |
| K925294 | PRECISA | Feb 23, 1994 | Substantially Equivalent | RUDOLF RIESTER GMBH & CO. KG |
| K932823 | BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK | Feb 17, 1994 | Substantially Equivalent | PORTABLE POWER SYSTEMS, INC. |
| K935872 | NAMTAI | Jan 24, 1994 | Substantially Equivalent | NAM TAI ELECTRONICS (CANADA) LTD. |
| K935652 | NAMTAI | Dec 29, 1993 | Substantially Equivalent | NAM TAI ELECTRONICS (CANADA) LTD. |
| K932109 | PROFILOMAT | Dec 03, 1993 | Substantially Equivalent | QMED, INC. |
| K923344 | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR | Oct 07, 1993 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K925402 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300 | Sep 17, 1993 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K923595 | SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR | Jul 01, 1993 | Substantially Equivalent | ADVANCED MEDICAL INSTRUMENTS, INC. |
| K921048 | BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST | Jul 01, 1993 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K915697 | CRITIKON VITAL SIGNS MODULE | Jul 01, 1993 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K930798 | OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. | May 13, 1993 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K924910 | SYSTEM 7500 NIBP/SA02 | May 13, 1993 | Substantially Equivalent | ADVANCED MEDICAL INSTRUMENTS, INC. |
| K920778 | OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 | Dec 24, 1992 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K914823 | OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706 | Dec 23, 1992 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K924210 | NAMTAI ELECTRONIC BLOOD PRESSURE METER | Nov 20, 1992 | Substantially Equivalent | NAM TAI ELECTRONICS (CANADA) LTD. |
| K914765 | SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS | Nov 06, 1992 | Substantially Equivalent | SIEMENS MEDICAL ELECTRONICS |
| K921627 | DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101 | Nov 03, 1992 | Substantially Equivalent | SHOWA ENGINEERING CO., LTD. |
| K921074 | BP PUMP | Oct 09, 1992 | Substantially Equivalent | BIO-TEK INSTRUMENTS, INC. |
| K912815 | NIBP 9225 COMBI | Oct 09, 1992 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K915468 | MODEL P-81 CRITIKON PRINTER | Sep 22, 1992 | Substantially Equivalent | CRITKON, INC. |
| K914260 | 4240 DYNAMIC BP/HEART RATE MONITOR | Sep 04, 1992 | Substantially Equivalent | SUNTECH MEDICAL INSTRUMENTS, INC. |
| K913844 | ACCUTRACKER DX | Jul 14, 1992 | Substantially Equivalent | SUNTECH MEDICAL INSTRUMENTS, INC. |
| K913595 | DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Mar 27, 1992 | Substantially Equivalent | KOVEN AND ASSOC., INC. |
| K911645 | NGM NIBP MODULE | Mar 04, 1992 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K911722 | OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630 | Jan 22, 1992 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K912588 | AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS | Dec 19, 1991 | Substantially Equivalent | SEIN ELECTRONICS CO., LTD. |
| K911871 | CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS | Nov 07, 1991 | Substantially Equivalent | CARDIODYNE, INC. |
| K913523 | AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR | Nov 06, 1991 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K911965 | ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR | Oct 28, 1991 | Substantially Equivalent | CITIZEN WATCH CO., LTD. |
| K910643 | CASIO BP-100 | Sep 10, 1991 | Substantially Equivalent | CASIO, INC. |
| K912530 | CARDIOCAP II(TM) | Sep 05, 1991 | Substantially Equivalent | DATEX MEDICAL INSTRUMENTATION, INC. |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | Aug 22, 1991 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K912119 | DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 | Aug 07, 1991 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K912118 | DIGITAL SPHYGMOMANOMETER MODEL UA-833 | Aug 07, 1991 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K911049 | DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 | Aug 07, 1991 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K903237 | CARDIOCAP CMX-104 MONITOR | Jul 17, 1991 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K904298 | EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR | Jun 21, 1991 | Substantially Equivalent | MEDI-SWISS CORP. |
| K911310 | COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD | Jun 10, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K910772 | PROPAQ 102, 104 AND 106 | Apr 12, 1991 | Substantially Equivalent | PROTOCOL SYSTEMS, INC. |
| K905367 | E-20 RAPID CUFF INFLATOR | Mar 06, 1991 | Substantially Equivalent | D. E. HOKANSON, INC. |
| K903771 | HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE | Feb 19, 1991 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K903133 | OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C | Jan 18, 1991 | Substantially Equivalent | OMRON MARSHALL PRODUCTS, INC. |
| K904739 | DYNAPULSE 200M | Jan 08, 1991 | Substantially Equivalent | PULSE METRIC, INC. |
| K903134 | OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C | Jan 08, 1991 | Substantially Equivalent | OMRON MARSHALL PRODUCTS, INC. |
| K904318 | LOCAL REPORT GENERATOR | Dec 18, 1990 | Substantially Equivalent | SPACELABS, INC. |
| K897173 | SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR | Oct 23, 1990 | Substantially Equivalent | ADVANCED MEDICAL INSTRUMENTS, INC. |
| K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR | Sep 04, 1990 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K901392 | BP50 BLOOD PRESSURE AND PULSE MONITOR | Aug 23, 1990 | Substantially Equivalent | PULSE TIME PRODUCTS, LTD. |
| K901889 | FUKUDA DENSHI MODEL HJ-310 | Jul 17, 1990 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K900247 | CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM | Jul 17, 1990 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K896958 | ESCORT NON-INVASIVE BLOOD PRESSURE OPTION | Mar 13, 1990 | Substantially Equivalent | MEDICAL DATA ELECTRONICS |
| K894563 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F | Mar 06, 1990 | Substantially Equivalent | OMRON ELECTRONICS, INC. |
| K896633 | AUTO-CUFF(TM) | Feb 01, 1990 | Substantially Equivalent | U.S. MEDICAL CORP. |
| K882955 | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 | Jan 26, 1990 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K896102 | MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR | Jan 18, 1990 | Substantially Equivalent | ADVANCED MEDICAL PRODUCTS, INC. |
| K895429 | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 | Nov 28, 1989 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K895428 | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 | Nov 28, 1989 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K894945 | NON-INVASIVE BLOOD PRESSURE MODULE | Oct 26, 1989 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K894693 | AP-851PA NIBP MODULE | Oct 02, 1989 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K894062 | ELECTRONIC BLOOD PRESSURE MONITORS | Aug 24, 1989 | Substantially Equivalent | HANSON SCALE CO. |
| K890198 | PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350) | Jun 12, 1989 | Substantially Equivalent | PARAMED TECHNOLOGY, INC. |
| K885191 | MRL BLOOD PRESSURE MONITOR | May 23, 1989 | Substantially Equivalent | MEDICAL RESEARCH LABORATORIES, INC. |
| K884405 | FORTEC MI-150 DIGITAL BLOOD PRESSURE METER | May 19, 1989 | Substantially Equivalent | NAM TAI ELECTRONIC & ELECTRICAL PRODUCTS, LTD. |
| K890005 | TYPE 9225 NIBP | May 11, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K884885 | BP-408 MARK II | Feb 23, 1989 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K884742 | ESCORT NON-INVASIVE BLOOD PRESSURE OPTION | Feb 02, 1989 | Substantially Equivalent | MEDICAL DATA ELECTRONICS |
| K882825 | TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN | Jan 17, 1989 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K882824 | TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR | Jan 17, 1989 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K881771 | SENSOCOR(TM) DIASYS | Jan 12, 1989 | Substantially Equivalent | SENSORMEDIX, INC. |
| K884955 | CARDIOCAP(TM) CM-104 MONITOR | Dec 28, 1988 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K882635 | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR | Nov 09, 1988 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K880599 | POCKET MANOMETER | Oct 06, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K882393 | DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP | Aug 30, 1988 | Substantially Equivalent | OMRON ELECTRONICS, INC. |
| K882188 | MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR | Jul 28, 1988 | Substantially Equivalent | IVY BIOMEDICAL SYSTEMS, INC. |
| K881155 | MODEL BPS08 BLOOD PRESSURE MODULE | Jul 28, 1988 | Substantially Equivalent | FRESENIUS USA, INC. |
| K881272 | ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING | Jun 22, 1988 | Substantially Equivalent | ACCUSTAT, INC. |
| K881269 | OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C | Jun 16, 1988 | Substantially Equivalent | OMRON ELECTRONICS, INC. |
| K881602 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C | Jun 15, 1988 | Substantially Equivalent | OMRON TATEISI ELECTRONICS CO. |
| K881601 | OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C | Jun 15, 1988 | Substantially Equivalent | OMRON TATEISI ELECTRONICS CO. |
| K873764 | AMBULATORY BLOOD PRESSURE MONITOR | Jun 10, 1988 | Substantially Equivalent | PULSETREND, INC. |
| K881003 | DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 | May 18, 1988 | Substantially Equivalent | HEALTHCHECK CORP. |
| K880572 | OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR | May 10, 1988 | Substantially Equivalent | OHMEDA MEDICAL |
| K874917 | PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | May 10, 1988 | Substantially Equivalent | OXFORD MEDILOG, INC. |
| K880715 | (MB-650) BLOOD PRESSURE MONITOR | May 09, 1988 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K880351 | VITAL SYSTEM | Mar 22, 1988 | Substantially Equivalent | PACE TECH, INC. |
| K875265 | NON-INVASIVE BLOOD PRESSURE MODULE | Feb 29, 1988 | Substantially Equivalent | PPG INDUSTRIES, INC. |
| K875093 | NEW MODEL MB-550 BLOOD PRESSURE MONITOR | Feb 05, 1988 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K874378 | DINAMAP VITAL SIGNS MONITOR, MODEL 8100T | Dec 30, 1987 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K873979 | DYNAMARK 1000 | Nov 27, 1987 | Substantially Equivalent | DYNAMEDICS, INC. |
| K872629 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741 | Sep 15, 1987 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K872355 | COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 | Sep 15, 1987 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K871886 | MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT | Jul 29, 1987 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K871418 | VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) | Jul 29, 1987 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K861374 | SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 | Jul 21, 1987 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K864411 | PULSE/B.P. MONITOR | Jun 24, 1987 | Substantially Equivalent | PULSE TIME PRODUCTS, LTD. |
| K871794 | EASY READ(TM) | Jun 19, 1987 | Substantially Equivalent | HEALTH O METER |
| K871719 | MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER | Jun 05, 1987 | Substantially Equivalent | A & D ENGINEERING, INC. |
| K871482 | HYPERTENSION RISK DETECTOR(TM) | Jun 05, 1987 | Substantially Equivalent | PEARCE CLINICAL LABORATORIES, INC. |
| K871363 | MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE | Jun 05, 1987 | Substantially Equivalent | QUINTON, INC. |
| K870460 | DORROS(TM) SMALL VESSEL PTA CATHETER | Jun 05, 1987 | Substantially Equivalent | C.R. BARD, INC. |
| K871207 | OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C | May 28, 1987 | Substantially Equivalent | OMRON ELECTRONICS, INC. |
| K870049 | EMT-102 CARDIAC MONITOR | Apr 22, 1987 | Substantially Equivalent | EVERGREEN MEDICAL TECHNOLOGIES, INC. |
| K862427 | MODIFIED DRAGER SPHYGMOMED | Mar 23, 1987 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K864318 | THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM | Mar 20, 1987 | Substantially Equivalent | THE BUDDY SYSTEMS, INC. |
| K864737 | NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340 | Mar 12, 1987 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K863891 | MODIFIED STBP-680 | Feb 19, 1987 | Substantially Equivalent | QUINTON, INC. |
| K864654 | COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR | Feb 10, 1987 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K861987 | 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF | Feb 03, 1987 | Substantially Equivalent | OHMEDA MEDICAL |
| K861856 | NBP 488, TPR 488 | Dec 22, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K864666 | MODIFIED LIFESTAT 200 | Dec 11, 1986 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K864665 | MODIFIED VSM 2 VITAL SIGNS MONITOR | Dec 11, 1986 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K863672 | MODEL (MB-700) BLOOD PRESSURE MONITOR | Nov 18, 1986 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K855048 | NORELCO DIGITAL BLOOD PRESSURE METER HC3001 | Nov 17, 1986 | Substantially Equivalent | PHILIPS PARK |
| K854279 | NORELCO ELECTRONIC DIGITAL BP METER HC3030 | Nov 17, 1986 | Substantially Equivalent | PHILIPS PARK |
| K855177 | NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER | Nov 07, 1986 | Substantially Equivalent | PHILIPS PARK |
| K861504 | MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR | Aug 25, 1986 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K860488 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 | Aug 25, 1986 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K855127 | AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 | Aug 14, 1986 | Substantially Equivalent | SPACELABS, INC. |
| K862756 | PREGELLED INFANT DISPOSABLE ECG ELECTRODE | Aug 06, 1986 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K861375 | MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS | Aug 06, 1986 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K861364 | NEOGUARD ECG ELECTRODES | Aug 06, 1986 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K860634 | PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP | Jul 01, 1986 | Substantially Equivalent | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
| K854481 | COLIN ELECTRONICS CO., LTD. STBP 680 | Jun 09, 1986 | Substantially Equivalent | COLIN MEDICAL INSTRUMENTS CORP. |
| K853561 | LIFESTAT 100 | Jun 09, 1986 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K854942 | HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP. | Jun 02, 1986 | Substantially Equivalent | MENNEN MEDICAL, INC. |
| K854434 | DINAMAP VITAL SIGNS MONITOR MODEL 8100 | May 16, 1986 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K860196 | OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 | May 12, 1986 | Substantially Equivalent | CAS MEDICAL SYSTEMS, INC. |
| K854797 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731 | May 09, 1986 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K860287 | PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 | Apr 28, 1986 | Substantially Equivalent | HEALTHCHECK CORP. |
| K854370 | MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR | Apr 28, 1986 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K854201 | OMRON DIGITAL BP MONITOR HEM-700CP | Apr 17, 1986 | Substantially Equivalent | OMRON TATEISI ELECTRONICS CO. |
| K853599 | LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI | Mar 21, 1986 | Substantially Equivalent | LITTON DATAMEDIX |
| K852574 | WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C | Mar 13, 1986 | Substantially Equivalent | WELCH ALLYN, INC. |
| K852421 | SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR | Feb 26, 1986 | Substantially Equivalent | NBS MEDICAL, INC. |
| K852978 | COMFORT - CUF | Jan 14, 1986 | Substantially Equivalent | DYNASTY INSTRUMENTS, LTD. |
| K852653 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 | Dec 30, 1985 | Substantially Equivalent | HEALTHTEAM |
| K852459 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175 | Dec 30, 1985 | Substantially Equivalent | HEALTHTEAM |
| K852458 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145 | Dec 30, 1985 | Substantially Equivalent | HEALTHTEAM |
| K852457 | HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165 | Dec 30, 1985 | Substantially Equivalent | HEALTHTEAM |
| K853260 | OMRON DIGITAL BP MONITOR HEM-700C | Nov 18, 1985 | Substantially Equivalent | OMRON TATEISI ELECTRONICS CO. |
| K852795 | SUNBEAM HEALTH MONITOR MODEL NO. 7600 | Nov 18, 1985 | Substantially Equivalent | AANSON SCALE CO. |
| K853158 | DIGITAL SPHYGMOMANOMETER MODEL 7620 | Nov 14, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K840574 | EBM-500 | Nov 14, 1985 | Substantially Equivalent | BOSCH HEARING INSTRUMENTS, INC. |
| K852128 | NORELCO ELECTRONIC DIGITAL BP METER HC3501 | Sep 12, 1985 | Substantially Equivalent | PHILIPS PARK |
| K851223 | COPAL DIGITAL SPHYGMOMANOMETER UA-560 | Sep 09, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K852564 | COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR | Aug 19, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K851707 | OMRON DIGITAL BP MONITOR HEM-400C | Jul 31, 1985 | Substantially Equivalent | OMRON TATEISI ELECTRONICS CO. |
| K851664 | MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO | Jul 24, 1985 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K844252 | MODEL 9300 TREND ANALYZING BIO-MONITOR SYS | Jun 26, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K850830 | SHARP DIGITAL BP MONITOR MB-371H | Jun 13, 1985 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K852037 | NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER | Jun 11, 1985 | Substantially Equivalent | PHILIPS PARK |
| K843010 | BP-800 | May 29, 1985 | Substantially Equivalent | POLLENEX ASSOCIATED MILLS, INC. |
| K843055 | ACCU-TRAC | May 28, 1985 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K851049 | NORELCO BLOOD PRESSURE METER | May 16, 1985 | Substantially Equivalent | PHILIPS PARK |
| K850893 | BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE | May 16, 1985 | Substantially Equivalent | SUN DANCE TECHNOLOGY, INC. |
| K850867 | ACCUTRACKER HEART-RATE MONITOR | May 16, 1985 | Substantially Equivalent | EUTECTIC ELECTRONICS, INC. |
| K843446 | DIGITAL SPHYGMOMANOMETER BP-2500 | May 15, 1985 | Substantially Equivalent | POLLENEX ASSOCIATED MILLS, INC. |
| K843390 | COPAL DIGITAL SPHYGMOMANOMETER UA-535 | May 15, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K850477 | NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050 | Apr 29, 1985 | Substantially Equivalent | UNISONIC PRODUCTS CORP. |
| K850476 | NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050 | Apr 29, 1985 | Substantially Equivalent | UNISONIC PRODUCTS CORP. |
| K850318 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050 | Apr 18, 1985 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K844310 | BLOOD-PRESSURE ECG TRANSMITTER | Apr 18, 1985 | Substantially Equivalent | INSTROMEDIX, INC. |
| K844285 | COPAL DIGITAL SPHYGMOMAMOMETER UA-550 | Apr 18, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K850317 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050 | Apr 16, 1985 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K850316 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 | Apr 16, 1985 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K850315 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050 | Apr 16, 1985 | Substantially Equivalent | NIHON SEIMITSU SOKKI CO., LTD. |
| K844839 | DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX | Apr 01, 1985 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K844353 | PHYSIOLOGICAL MONITOR 2100 | Apr 01, 1985 | Substantially Equivalent | DATASCOPE CORP. |
| K842538 | ACCUTORR CSM SYSTEM | Mar 01, 1985 | Substantially Equivalent | DATASCOPE CORP. |
| K842067 | CALCULATING CUFF INFLATOR TD312 | Mar 01, 1985 | Substantially Equivalent | D. E. HOKANSON, INC. |
| K842318 | YKI-770 ELECTRONIC SPHYGMOMAMETER | Feb 14, 1985 | Substantially Equivalent | YUKOSHA CO., INC. |
| K842388 | COPAL DIGITAL SPHYGMOMANOMETER UA-510 | Feb 13, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K844284 | COPAL DIGITAL SPHYGMOMANOMETER UA-540 | Feb 08, 1985 | Substantially Equivalent | TAKEDA MEDICAL, INC. |
| K850070 | HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 | Jan 22, 1985 | Substantially Equivalent | HEALTHCHECK CORP. |
| K843137 | BP 5000 | Jan 16, 1985 | Substantially Equivalent | TECH VEND MARKETING |
| K841246 | PORTABLE NURSING UNIT TERMINAL | Nov 08, 1984 | Substantially Equivalent | NCR CORP. |
| K840932 | MUSE-DP | Oct 30, 1984 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K841336 | NON-INVASIVE BP MODULE 7000 | Oct 26, 1984 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K841103 | NONINVASIVE BLOOD PRESSURE MEASURE SYS | Oct 26, 1984 | Substantially Equivalent | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
| K832076 | ELECTRONIC BLOOD PRESS. METER EN-212 | Oct 26, 1984 | Substantially Equivalent | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
| K842200 | MD308H DIGITAL/MB351H AUTO-BP MONITOR | Oct 24, 1984 | Substantially Equivalent | SHARP ELECTRONICS CORP. |
| K843009 | BP-1000 | Aug 24, 1984 | Substantially Equivalent | POLLENEX ASSOCIATED MILLS, INC. |
| K842486 | ELECTRONIC DIGITAL BP METER HC 3001 | Aug 24, 1984 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K841095 | BP800, 850 1000 | Aug 24, 1984 | Substantially Equivalent | ASSOCIATED MILLS, INC. |
| K840909 | AUTOMATED NON-INVASIVE PRESSURE MODULE | Jun 15, 1984 | Substantially Equivalent | GOULD, INC. |
| K841381 | DIGITAL SPHYGMOMANOMETER UA-273 | Jun 14, 1984 | Substantially Equivalent | PROMEDICAL INDUSTRIES, INC. |
| K841380 | DIGITAL SPHYGMOMANOMETER UA-254 | Jun 14, 1984 | Substantially Equivalent | PROMEDICAL INDUSTRIES, INC. |
| K841616 | TIMEX HEALTHCHECK DIGITAL BP MONITOR | Jun 05, 1984 | Substantially Equivalent | TIMEX MEDICAL PRODUCTS CORP. |
| K840162 | DRAGER SPHYGMOMED | May 30, 1984 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent | SYBRON CORP. |
| K834441 | BLOOD PRESSURE MONITOR BP600X | May 21, 1984 | Substantially Equivalent | LIFELINE SYSTEMS, INC. |
| K833799 | SPHYGOMANO METER | May 14, 1984 | Substantially Equivalent | FRASER HARLAKE, INC. |
| K840228 | HEALTHCHECK AUTO INFLATE DIGITAL BP | May 09, 1984 | Substantially Equivalent | TIMEX MEDICAL PRODUCTS CORP. |
| K832721 | DIGITAL SPHYGMOMANOMETER UA-231 | Apr 19, 1984 | Substantially Equivalent | COPAL, INC. |
| K832723 | DIGITAL SPHGMOMANOMETER UA-271 | Apr 17, 1984 | Substantially Equivalent | COPAL, INC. |
| K832722 | DIGITAL SPHYGMOMANOMETER UA-251 | Apr 17, 1984 | Substantially Equivalent | COPAL, INC. |
| K833978 | OMEGA 5000 | Mar 09, 1984 | Substantially Equivalent | INVIVO RESEARCH LABS, INC. |
| K833753 | AC ADAPTERS FOR BLOOD PRESSURE METERS | Jan 30, 1984 | Substantially Equivalent | PHILIPS PARK |
| K833583 | VERIFORM II | Jan 30, 1984 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K832764 | ALPHA NON-INVASIVE BP CARDULE | Jan 27, 1984 | Substantially Equivalent | SPACELABS, INC. |
| K830338 | NARCOTRACE 80 | Dec 22, 1983 | Substantially Equivalent | NARCO SCIENTIFIC |
| K832656 | DINAMAP VITAL SIGNS MONITOR #1846P | Nov 07, 1983 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K832060 | ACCU-SPHYG | Oct 19, 1983 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K831245 | TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO | Oct 19, 1983 | Substantially Equivalent | RITTER CO. |
| K832171 | SELF CHECK DIGITAL BLOOD PRESS. MONITOR | Oct 04, 1983 | Substantially Equivalent | RITTER CO. |
| K832075 | ELECTRONIC BLOOD PRESS. METER-ZH-820P | Aug 12, 1983 | Substantially Equivalent | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
| K831151 | PANASONIC MODEL EW-213 | Aug 11, 1983 | Substantially Equivalent | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
| K830682 | CARDIVAN BLOOD PRESSURE MONITOR | Aug 11, 1983 | Substantially Equivalent | PARAMED TECHNOLOGY, INC. |
| K831232 | LIFESTAT 200 | Jul 28, 1983 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K831583 | GP-303 | Jul 19, 1983 | Substantially Equivalent | HIRATA SANGYO CO. USA, INC. |
| K831515 | DINAMAP VITAL SIGNS MONITOR #1846 | Jun 30, 1983 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K830713 | LS-1 PORTABLE BLOOD PRESSURE COMPUTER | Jun 08, 1983 | Substantially Equivalent | VITA-STAT MEDICAL SERVICES, INC. |
| K830687 | NORELCO ELECTRONIC ANALOG BLOOD PRESS | May 18, 1983 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K830686 | ANEROID BLOOD PRESSURE CUFF #HC1400 | May 18, 1983 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K830685 | NORELCO DELUXE DIGITAL BLOOD PRESSURE | May 18, 1983 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K830684 | NORELCO ELECTRONIC DIGITAL BLOOD PRESS | May 18, 1983 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K830184 | SPHYGMOLOG II MODEL D | Apr 12, 1983 | Substantially Equivalent | CARDIODYNE GENERAL, INC. |
| K830368 | AMBULATORY BLOOD PRESSURE MONITOR | Mar 31, 1983 | Substantially Equivalent | VITA-STAT MEDICAL SERVICES, INC. |
| K823501 | ZEE SPHYGMOMANOMETER | Jan 21, 1983 | Substantially Equivalent | ZEE MEDICAL PRODUCTS CO., INC. |
| K823052 | THE 500 MONITOR SERIES | Nov 30, 1982 | Substantially Equivalent | VITATEK |
| K822102 | PRESS-O-TEST | Nov 24, 1982 | Substantially Equivalent | MEDI-SWISS CORP. |
| K822055 | CNIBP BLOOD PRESSURE MEASUREMENT SYS | Nov 01, 1982 | Substantially Equivalent | OHIO MEDICAL PRODUCTS |
| K821989 | NON-STETHO 7, UM-15TP | Oct 18, 1982 | Substantially Equivalent | HIRATA SANGYO CO. USA, INC. |
| K822614 | BLOOD PRESSURE MONITORING DEVICES | Sep 21, 1982 | Substantially Equivalent | ALLIED HEALTHCARE PRODUCTS, INC. |
| K822438 | BIOMEGA MODEL 59W | Sep 21, 1982 | Substantially Equivalent | BIO MEGA DIAGNOSTIC, INC. |
| K821614 | AS20 MONITORING SYSTEM | Jul 14, 1982 | Substantially Equivalent | NARCO SCIENTIFIC |
| K821378 | NON-INVASIVE AUTOMATIC BLOOD PRESSURE | Jul 08, 1982 | Substantially Equivalent | NARCO SCIENTIFIC |
| K820854 | KENZ-45M | Jun 01, 1982 | Substantially Equivalent | SUZUKEN CO., LTD. |
| K821437 | DIGITAL BLOOD PRESSURE METER | May 28, 1982 | Substantially Equivalent | TIMEX MEDICAL PRODUCTS CORP. |
| K820667 | PRESSURE-STAT | May 18, 1982 | Substantially Equivalent | ALVIN H. SACKS, PH.D. |
| K813522 | AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR | Apr 01, 1982 | Substantially Equivalent | VITAR |
| K820300 | ELECTRONIC DIGITAL SPHYGMOMANOMETER | Mar 25, 1982 | Substantially Equivalent | COPAL, INC. |
| K820569 | IVAC #1160 MULTIPLE VITAL SIGNS UNIT | Mar 18, 1982 | Substantially Equivalent | Y |
| K820402 | PATIENT FOLLOW-UP COMPUTER (PFC | Mar 12, 1982 | Substantially Equivalent | MEDICAL SYSTEMS, INC. |
| K820242 | DIGICUFF | Mar 04, 1982 | Substantially Equivalent | NOVATEC, INC. |
| K820135 | TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER | Mar 01, 1982 | Substantially Equivalent | SYBRON CORP. |
| K813385 | DIGITAL BLOOD PRESSURE UNIT | Jan 29, 1982 | Substantially Equivalent | CONPHAR, INC. |
| K813556 | MOD. 587 BLOOD PRESSURE & PULSE MONITOR | Jan 22, 1982 | Substantially Equivalent | BIO MEGA DIAGNOSTIC, INC. |
| K813527 | DINAMAP ADULT/PED./NEONATAL VITAL SIGNS | Jan 12, 1982 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K812936 | BLOOD PRESSURE MONITOR | Dec 14, 1981 | Substantially Equivalent | AMERTEK |
| K812409 | SPHYGMOMANOMETER | Nov 02, 1981 | Substantially Equivalent | SOMATRONIX RESEARCH CORP. |
| K812259 | NIVP MONITOR | Sep 21, 1981 | Substantially Equivalent | DATASCOPE CORP. |
| K812059 | SPHGOMOMANOMETER | Aug 13, 1981 | Substantially Equivalent | MED-TEK CORP. |
| K811781 | TENSIOMETER | Jul 10, 1981 | Substantially Equivalent | VIVITEK, INC. |
| K811636 | NORELCO ELECTRONIC BLOOD PRESSURE METER | Jun 30, 1981 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K811635 | NORELCO DIGITAL BLOOD PRESSURE METER | Jun 30, 1981 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K811188 | NORELCO BLOOD PRESSURE METER | May 15, 1981 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K802412 | BLOOD PRESSURE UNIT MODEL 410 | Dec 16, 1980 | Substantially Equivalent | JS & A GROUP |
| K802411 | BLOOD PRESSURE UNIT MODEL 310 | Dec 16, 1980 | Substantially Equivalent | JS & A GROUP |
| K802191 | ATGM MODEL AT-80 | Nov 12, 1980 | Substantially Equivalent | HERALD OF AMERICA, INC. |
| K802218 | SD-900 OSCILLOMETRIC BP MONITOR | Oct 23, 1980 | Substantially Equivalent | INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
| K802202 | SD-800 BLOOD PRESSURE MONITOR | Oct 23, 1980 | Substantially Equivalent | INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
| K802201 | SD-700 BLOOD PRESSURE MONITOR | Oct 23, 1980 | Substantially Equivalent | INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
| K802203 | CM-700A AUTO-INFLATE CONTROL MODULE | Oct 03, 1980 | Substantially Equivalent | INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
| K801923 | BIOMEGA #423-B BLOOD PRESSURE & PULSE CK | Aug 27, 1980 | Substantially Equivalent | BIO MEGA DIAGNOSTIC, INC. |
| K801657 | NON-INVASIVE, BLOOD PRESSURE MONITOR | Aug 20, 1980 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K801389 | BARO/TRAC II & VITA/TRAC, VITAL SIGN MON | Jul 28, 1980 | Substantially Equivalent | BIB, INC. |
| K800596 | VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR | Jul 21, 1980 | Substantially Equivalent | BIB, INC. |
| K801187 | CONPHAR CHECKMATE SPHYGMOMANOMETER | Jun 09, 1980 | Substantially Equivalent | CONPHAR, INC. |
| K800904 | TONOTEST BLOOD PRESSURE MONITOR | Jun 04, 1980 | Substantially Equivalent | RETLIF, INC. |
| K800778 | DIGITAL ELECTRONIC B.P. MONITOR 2155 | Apr 29, 1980 | Substantially Equivalent | SEARS, ROEBUCK & CO. |
| K800663 | MARK III | Apr 08, 1980 | Substantially Equivalent | APPLIED SCIENCE LABORATORIES |
| K800662 | MARK II | Apr 08, 1980 | Substantially Equivalent | APPLIED SCIENCE LABORATORIES |
| K800661 | MODEL S/D-600 AUTO INFLATE CONTROL MODUL | Apr 08, 1980 | Substantially Equivalent | APPLIED SCIENCE LABORATORIES |
| K800614 | MEDTEK #411 PORTABLE B-P INSTR. | Apr 02, 1980 | Substantially Equivalent | MED-TEK CORP. |
| K800401 | INFRASONDE D4000 ELECTRONIC B-P MONITOR | Mar 12, 1980 | Substantially Equivalent | SPHYGMETRICS, INC. |
| K800225 | MICRONTA BP-1 ELECTRONIC B/P TESTER | Mar 10, 1980 | Substantially Equivalent | TANDY CORP. |
| K800066 | NIASTAT | Feb 29, 1980 | Substantially Equivalent | INVIVO RESEARCH LABS, INC. |
| K800025 | DINAMAP RESEARCH MONITOR 1245 | Feb 01, 1980 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K792653 | SENTRY | Jan 04, 1980 | Substantially Equivalent | AUTOMATED SCREENING DEVICES |
| K792075 | MODEL 1978 PRESSUROMETER III AMBULATORY | Dec 04, 1979 | Substantially Equivalent | DEL MAR AVIONICS |
| K792194 | VITA-STAT MODEL 900-S | Nov 20, 1979 | Substantially Equivalent | VITA-STAT MEDICAL SERVICES, INC. |
| K792193 | VITA-STAT MODEL 900-D | Nov 20, 1979 | Substantially Equivalent | VITA-STAT MEDICAL SERVICES, INC. |
| K792192 | VITA-STAT MODEL 900A | Nov 13, 1979 | Substantially Equivalent | VITA-STAT MEDICAL SERVICES, INC. |
| K791637 | TENS-O-TEST | Sep 12, 1979 | Substantially Equivalent | CUROMATIC, INC. |
| K791159 | DINAMAP MODEL 855 | Jul 30, 1979 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K791054 | HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC | Jul 10, 1979 | Substantially Equivalent | C.R. BARD, INC. |
| K790537 | AUTOMATIC ELECTRONIC SPHYMOMONOMETER | May 08, 1979 | Substantially Equivalent | HEALTHCARE ENTERPRISES, INC. |
| K790470 | THE GUARDIAN SPHYGMOMANOMETER | Mar 16, 1979 | Substantially Equivalent | WORLD BOOK ENCYCLOPEDIA, INC. |
| K790277 | QUICK-CHECK | Mar 16, 1979 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K790328 | MODEL 1051, MONITOR | Mar 02, 1979 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K781517 | AUTOMATIC BLOOD PRESSURE DEVICE | Jan 11, 1979 | Substantially Equivalent | WELCH ALLYN, INC. |
| K782000 | MONITOR, NON-INVASIVE BLOOD PRESSURE | Dec 05, 1978 | Substantially Equivalent | AUTOMATED SCREENING DEVICES |
| K781932 | BLOOD PRESSURE RECORDER | Nov 29, 1978 | Substantially Equivalent | CARDIODYNE, INC. |
| K781906 | BLOOD PRESSURE DEVICE, 400 SERIES | Nov 16, 1978 | Substantially Equivalent | MED-TEK CORP. |
| K781556 | PRESSURE INFUSION CUFF | Oct 17, 1978 | Substantially Equivalent | ABBOTT LABORATORIES |
| K780986 | DIGITAL BLOOD PRESSURE MONITOR | Jul 18, 1978 | Substantially Equivalent | SEARS, ROEBUCK & CO. |
| K780754 | NEONATAL MONITOR | Jun 14, 1978 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K780805 | S/D 600 SPHYGMOMANOMETER AND PULSEMETER | Jun 06, 1978 | Substantially Equivalent | G & W APPLIED SCIENCE LABORATORIES |
| K780598 | TREND II ANEROID | Jun 06, 1978 | Substantially Equivalent | ABCO DEALERS, INC. |
| K780358 | ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 | Apr 28, 1978 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K780566 | HEALTH SEAT SYSTEM | Apr 21, 1978 | Substantially Equivalent | G & W APPLIED SCIENCE LABORATORIES |
| K780046 | ULTRASPHYG BLOOD PRESSURE OPTION | Mar 15, 1978 | Substantially Equivalent | CAVITRON CORP. |
| K771393 | ELHCTRONIC SPHYGMOMANOMETER | Nov 11, 1977 | Substantially Equivalent | C.R. BARD, INC. |
| K771394 | ELECTRONIC STETHESCOPE | Nov 09, 1977 | Substantially Equivalent | C.R. BARD, INC. |
| K771931 | MONITOR, DINMAP, MODEL 850 | Oct 27, 1977 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K771897 | DINAMAP MODEL 837 | Oct 25, 1977 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K771896 | DINAMAP MODEL 835 | Oct 25, 1977 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K771895 | DINAMAP MADEL 845 | Oct 25, 1977 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K771782 | DINIMAP MODEL 827A | Oct 04, 1977 | Substantially Equivalent | APPLIED MEDICAL RESEARCH |
| K771449 | ARTEOIAL TONOMETER ML-105 | Sep 06, 1977 | Substantially Equivalent | NICOLET BIOMEDICAL INSTRUMENTS |
| K771500 | PRESSUROMETER II | Aug 16, 1977 | Substantially Equivalent | DEL MAR AVIONICS |
| K770921 | SPHYGMOMANOMETER, ELECTRONIC | Jun 02, 1977 | Substantially Equivalent | BRISTOLINE, INC. |
| K770357 | SPHYGMOMANOMETER, ELECTRONIC | Mar 01, 1977 | Substantially Equivalent | ISHIMOTO TRADING CO. |
| K760738 | AUTOMATIC ELECTRONIC SPHYGMOMANOMETER | Jan 21, 1977 | Substantially Equivalent | MEDICAL MONITORS, INC. |
| K761302 | ELECTRONIC BLOOD PRESSURE UNIT | Jan 05, 1977 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K761274 | BLOOD PRESSURE KIT, WELL-BE 669 | Jan 05, 1977 | Substantially Equivalent | PEARLDUCK, INC. |
| K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) | Dec 09, 1976 | Substantially Equivalent | ROCHE MEDICAL ELECTRONICS, INC. |
| K760930 | BLOOD PRESSURE & PULSE CHECKER | Nov 09, 1976 | Substantially Equivalent | BIO MEGA DIAGNOSTIC, INC. |
FEI Numbers
This FDA classification entry is associated with 420 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 420 registration numbers. Click on an entry to view related FDA registrations.