Product Code: DRT FDA class 2 21 CFR 870.2300

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cardiovascular

The Cardiac Monitor (including Cardiotachometer and Rate Alarm) is a cardiovascular monitoring device used to continuously observe and display the heart's electrical activity, calculate heart rate, and trigger alarms when the rate falls outside set limits, thereby supporting patient safety in clinical settings. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRT and it is regulated under 21 CFR 870.2300 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

339

FEI Numbers

103

Registration Numbers

103

Unique Applicants

161

Years Active

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Basic Information

Product Code: DRT
Device Class: FDA class 2
Regulation Number: 870.2300
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

Related 510(k) Clearances

This FDA classification is associated with 339 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261286	The Circadia C300 System (C300)	May 20, 2026	Substantially Equivalent	Circadia Health, Inc.
K252676	The Circadia C300 System (C300)	Feb 03, 2026	Substantially Equivalent	Circadia Health, Inc.
K253388	Sleepiz One+ (Model 2.5)	Jan 28, 2026	Substantially Equivalent	Sleepiz AG
K251364	Sleepiz One+ (2.5)	Jul 29, 2025	Substantially Equivalent	Sleepiz AG
K234003	The Circadia C200 System	May 30, 2024	Substantially Equivalent	Circadia Technologies, Ltd.
K232354	Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software	Mar 22, 2024	Substantially Equivalent	Murata Vios, Inc.
K231733	Neteera 130H-Plus Vital Sign Monitoring Sensor	Feb 09, 2024	Substantially Equivalent	Neteera Technologies , Ltd.
K223163	Sleepiz One+	Aug 18, 2023	Substantially Equivalent	Sleepiz AG
K212143	Neteera 130H/131H Vital Sign Monitoring Sensor	Sep 28, 2022	Substantially Equivalent	Neteera Technologies , Ltd.
K202138	Cardiac Trigger Monitor	May 14, 2021	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K202464	Vital Sign Monitoring Sensor (Model :XK300)	Apr 26, 2021	Substantially Equivalent	Xandar Kardian, Inc.
K181165	Philips wearable biosensor-G5 Solution	Mar 07, 2019	Substantially Equivalent	Connected Sensing- A Division of Philips Medical Systems
K172586	Vios Monitoring System Model 2050	Jun 22, 2018	Substantially Equivalent	Vios Medical, Inc.
K170828	Cardiac Trigger Monitor	May 17, 2017	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K151781	Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor	May 27, 2016	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K150992	Vios Monitoring System	Dec 16, 2015	Substantially Equivalent	Vios Medical, Inc.
K121860	ESA615	Jan 25, 2013	Substantially Equivalent	Fluke Biomedical
K121722	ESA620 ELECTRICAL SAFETY ANALYZER	Oct 11, 2012	Substantially Equivalent	Fluke Biomedical
K110429	PROSIM 4, PROSIM 6, PROSIM 8	Sep 02, 2011	Substantially Equivalent	Fluke Biomedical
K110987	CARDIAC TRIGGER MONITOR	Jul 22, 2011	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K103336	MPS450 MULTIPARAMETER SIMULATOR	Apr 13, 2011	Substantially Equivalent	Fluke Biomedical
K092809	HRV ACQUIRE	Oct 19, 2010	Substantially Equivalent	Wr Medical Electronics Co.
K102174	ZOLL PROPAQ M	Sep 15, 2010	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K100745	LIFEBED NETWORK PATIENT VIGILANCE SYSTEM	Apr 15, 2010	Substantially Equivalent	Hoana Medical, Inc.
K092037	LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM	Oct 02, 2009	Substantially Equivalent	Hoana Medical, Inc.
K091985	UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE	Jul 24, 2009	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K091050	506CN PATIENT MONITOR	May 27, 2009	Substantially Equivalent	Criticare Systems, Inc.
K083534	LIFEBED NETWORK PATIENT VIGILANCE SYSTEM	Apr 13, 2009	Substantially Equivalent	Hoana Medical, Inc.
K083854	CARDIAC TRIGGER, MODEL: CTM300	Feb 13, 2009	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K082626	PAM 3000	Jan 16, 2009	Substantially Equivalent	Wireless 2000 RF & Uwb Technologies , Ltd.
K082366	LIFEBED PATIENT VIGILANCE SYSTEM	Sep 26, 2008	Substantially Equivalent	Hoana Medical, Inc.
K063735	PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112	Sep 19, 2007	Substantially Equivalent	Presym, Inc.
K060307	12 RL ALGORITHM	Aug 04, 2006	Substantially Equivalent	Ge Medical Systems Information Technologies
K052446	LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM	Feb 02, 2006	Substantially Equivalent	Hoana Medical, Inc.
K051038	506 PATIENT MONITOR	Aug 12, 2005	Substantially Equivalent	Ciriticare Systems, Inc.
K033646	TRIFIT 700	Mar 01, 2005	Substantially Equivalent	Healthfirst Corp.
K043517	TRANSMITTER, ZS-940PA SERIES	Feb 03, 2005	Substantially Equivalent	Nihon Kohden America, Inc.
K043354	MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701	Jan 10, 2005	Substantially Equivalent	Invivo Research, Inc.
K032733	PM-8000 PATIENT MONITOR, MODEL 8000	Mar 03, 2004	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K030656	ENVAN HEART RATE MONITOR	Apr 08, 2003	Substantially Equivalent	Envan, LLC
K023616	PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)	Nov 04, 2002	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K022435	507EL VITAL SIGNS MONITOR	Aug 14, 2002	Substantially Equivalent	Criticare Systems, Inc.
K021681	MICROPAQ, MODELS 402, 404	Jul 23, 2002	Substantially Equivalent	Welch Allyn Protocol, Inc.
K020144	SIEMENS INFINITY SC 6002XL MODIFICATIONS	Feb 15, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K012763	SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM	Nov 15, 2001	Substantially Equivalent	Cobe Cardiovascular, Inc.
K012451	PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246	Aug 20, 2001	Substantially Equivalent	Welch Allyn Protocol, Inc.
K010587	ACTIVEECG	May 16, 2001	Substantially Equivalent	Active Corp.
K002061	A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR	Jan 19, 2001	Substantially Equivalent	A&D Engineering, Inc.
K001775	ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM	Jan 12, 2001	Substantially Equivalent	Zoe Medical, Inc.
K002725	MICROPAQ, MODELS 402 AND 404	Nov 21, 2000	Substantially Equivalent	Protocol Systems, Inc.
K992413	ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR	Aug 19, 1999	Substantially Equivalent	Medical Data Electronics
K992411	ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR	Aug 18, 1999	Substantially Equivalent	Medical Data Electronics
K984033	ATLAS MONITOR	Jul 08, 1999	Substantially Equivalent	Welch Allyn, Inc.
K981378	DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1	Nov 03, 1998	Substantially Equivalent	Datex-Engstrom, Inc.
K974581	MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT	Oct 28, 1998	Substantially Equivalent	Invivo Research, Inc.
K974178	PASSPORT 5L-CE MODEL 0998-00-0131XXX	Jun 26, 1998	Substantially Equivalent	Datascope Corp.
K973918	NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES	Jan 13, 1998	Substantially Equivalent	Nihon Kohden America, Inc.
K965158	HEART PROTECTOR (VER 1996)	Dec 09, 1997	Substantially Equivalent	N.P.N.T., Inc.
K972789	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016	Oct 17, 1997	Substantially Equivalent	Alexander Mfg. Co.
K972787	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P	Oct 17, 1997	Substantially Equivalent	Alexander Mfg. Co.
K963576	MOBILE MEDICAL MONITOR (M3(A))	Feb 28, 1997	Substantially Equivalent	Scientific Applications
K952790	LOG-A-RYTHM MODEL 100 AND MODEL 1001	Oct 17, 1996	Substantially Equivalent	Nian-Crae, Inc.
K960544	CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM	Aug 07, 1996	Substantially Equivalent	Nasiff Assoc., Inc.
K950688	OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM	Apr 18, 1996	Substantially Equivalent	Safety Tek Corp.
K952474	EAGLE 3000 PATIENT MONITOR	Oct 19, 1995	Substantially Equivalent	Marquette Electronics, Inc.
K941252	RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR	Sep 20, 1995	Substantially Equivalent	Ansar
K944262	ECG MONITOR	May 12, 1995	Substantially Equivalent	Fukuda Denshi USA, Inc.
K945071	PROPAQ 200 MONITOR	May 10, 1995	Substantially Equivalent	Protocol Systems, Inc.
K940081	MERCURY	Apr 12, 1995	Substantially Equivalent	Mennen Medical, Inc.
K943243	PULSE HEART RATE MONITOR	Mar 10, 1995	Substantially Equivalent	Sensor Dynamics, Inc.
K943242	PRO-SPORT HEART RATE MONITOR	Mar 10, 1995	Substantially Equivalent	Sensor Dynamics, Inc.
K934644	K3 SYSTEM	Nov 01, 1994	Substantially Equivalent	Astro-Med, Inc.
K934684	PAM CARDIAC MONITOR	Oct 17, 1994	Substantially Equivalent	Technology Transfer, Inc.
K944257	LIONHEART 3 MULTI-PARAMETER SIMULATOR	Sep 21, 1994	Substantially Equivalent	Bio-Tek Instruments, Inc.
K936051	OMNI-CENTRAL STATION MONITOR	Jul 06, 1994	Substantially Equivalent	Invivo Research, Inc.
K926298	520 DISPLAY DRIVER- STATUS I	May 04, 1994	Substantially Equivalent	Vidco, Inc.
K935817	MEDSIM 300 PATIENT SIMULATOR	Jan 18, 1994	Substantially Equivalent	Dynatech/Nevada, Inc.
K930004	ESCORT 100/300 SERIES B PATIENT MONITORS	Jun 23, 1993	Substantially Equivalent	Medical Data Electronics
K911611	SYSTEM ATHENA, MODIFICATION	Feb 05, 1993	Substantially Equivalent	S & W Medico Teknik
K921194	HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING	Nov 09, 1992	Substantially Equivalent	Hewlett-Packard Co.
K915624	MODIFIED BIOLOG	Mar 27, 1992	Substantially Equivalent	Micromedical Industries, Ltd.
K920099	GYMMAN	Mar 09, 1992	Substantially Equivalent	Lumiscope Co., Inc.
K910665	MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED	Dec 31, 1991	Substantially Equivalent	Ge Medical Systems Information Technologies
K914576	KELLER CARDIAC MONITOR MEDIL KMS870	Dec 30, 1991	Substantially Equivalent	Keller Medical Specialties Products, Inc.
K912049	SYSTEM ATHENA - PRODUCT ENHANCEMENTS	Dec 05, 1991	Substantially Equivalent	S & W Medico Teknik
K911598	DATASCOPE PASSPORT MONITOR	Oct 15, 1991	Substantially Equivalent	Datascope Corp.
K912008	TRU-VIEW MULTI-CHANNEL DISPLAY	Oct 09, 1991	Substantially Equivalent	General Devices
K910870	EDENTEC MODEL 3711 DIGITAL RECORDER	Aug 29, 1991	Substantially Equivalent	Edentec Corp.
K910852	507 NON-INVASIVE VITAL SIGNS MONITOR	Jul 30, 1991	Substantially Equivalent	Criticare Systems, Inc.
K903512	FUTURECARE CARELYNK IV SYSTEM	Jul 18, 1991	Substantially Equivalent	Futurecare Systems, Inc.
K905274	VITALMAX 2100/2200	Jul 17, 1991	Substantially Equivalent	Pace Tech, Inc.
K911616	HORIZON XL	Jul 10, 1991	Substantially Equivalent	Mennen Medical, Inc.
K911139	HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A	Jun 11, 1991	Substantially Equivalent	Hewlett-Packard Co.
K910882	PROPAQ 102EL, 104EL AND 106EL	May 08, 1991	Substantially Equivalent	Protocol Systems, Inc.
K904696	WEP-8430A TELEMETRY CENTRAL STATION	Feb 07, 1991	Substantially Equivalent	Nihon Kohden America, Inc.
K904353	CARDIOMATIC MODEL MSC-2001	Dec 20, 1990	Substantially Equivalent	Medical Systems Corp.
K902652	MORTARA INSTRUMENT MODEL ELI 50	Aug 23, 1990	Substantially Equivalent	Mortara Instrument, Inc.
K900451	VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE	Jul 18, 1990	Substantially Equivalent	Pace Tech, Inc.
K902608	CARDIOMATIC MODEL MSC-1001	Jul 13, 1990	Substantially Equivalent	Medical Systems Corp.
K901031	PCI MODEL 2041-PC TELEMETRY MONITOR	May 17, 1990	Substantially Equivalent	Accucore, Inc.
K896700	TYPE 9140/NEO	Apr 20, 1990	Substantially Equivalent	S & W Medico Teknik
K896699	TYPE 9040/NEO	Apr 20, 1990	Substantially Equivalent	S & W Medico Teknik
K901034	MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL	Apr 19, 1990	Substantially Equivalent	Nihon Kohden America, Inc.
K900032	MODEL M1175A/M1176A WITH ST SEGMENT MONITORING	Apr 10, 1990	Substantially Equivalent	Hewlett-Packard Co.
K895801	MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM	Apr 04, 1990	Substantially Equivalent	Marquette Electronics, Inc.
K895534	BIOLOG	Mar 19, 1990	Substantially Equivalent	Micromedical
K897080	CARDIOCAP(TM) CT-104 MONITOR	Mar 06, 1990	Substantially Equivalent	Datex Division Instrumentarium Corp.
K885085	ERGOMED 840/ERGOMED 840L	Oct 03, 1989	Substantially Equivalent	Burdick Corp.
K894700	TYPE PDU/CDU 9040 (SYSTEM ATHENA)	Oct 02, 1989	Substantially Equivalent	S & W Medico Teknik
K894699	TYPE 9140 (SYSTEM ATHENA)	Oct 02, 1989	Substantially Equivalent	S & W Medico Teknik
K893405	MODEL DS-504 DYNASCOPE PATIENT MONITOR	Oct 02, 1989	Substantially Equivalent	Fukuda Denshi USA, Inc.
K894919	NR5000 E.C.G. AND PULSE OXIMETER MONITOR	Sep 18, 1989	Substantially Equivalent	Nirad , Ltd.
K892795	PULSE TIME PRODUCTS LIMITED, PM-3	Aug 25, 1989	Substantially Equivalent	Pulse Time Products, Ltd.
K892794	PULSE TIME PRODUCTS LIMITED, PM-2	Aug 25, 1989	Substantially Equivalent	Pulse Time Products, Ltd.
K892066	HORIZON CENTRAL STATION	Jun 22, 1989	Substantially Equivalent	Mennen Medical, Inc.
K890876	BP-8800 BLOOD PRESSURE MONITOR	Jun 22, 1989	Substantially Equivalent	Colin Medical Instruments Corp.
K892006	HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S	May 23, 1989	Substantially Equivalent	Healthdyne, Inc.
K884804	THE COACH	May 19, 1989	Substantially Equivalent	Promark, Inc.
K884117	TYPE 9210 ECG SYSTEM ATHENA	Apr 26, 1989	Substantially Equivalent	S & W Medico Teknik
K884455	MODEL 702 ECG/RESPIRATION/TEMPERATURE	Mar 09, 1989	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K884096	PATIENT MONITOR MODEL 701	Feb 23, 1989	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K884645	PATIENT MONITOR RIGEL MODEL MULTICARE 429	Feb 02, 1989	Substantially Equivalent	Rigel Medical Electronics, Inc.
K882609	MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM	Jan 19, 1989	Substantially Equivalent	Waltham Div. Hewlett Packard
K883109	MINIMON 7136B PATIENT MONITOR	Jan 17, 1989	Substantially Equivalent	Kontron, Inc.
K883069	MINIMON 7134B PATIENT MONITOR	Jan 17, 1989	Substantially Equivalent	Kontron Instruments, Inc.
K884320	PROPAQ 106(TM)	Dec 27, 1988	Substantially Equivalent	Protocol Systems, Inc.
K875160	RIGEL MODEL MULTICARE 409	Jun 28, 1988	Substantially Equivalent	Rigel Medical Electronics, Inc.
K874148	MONITRON SYSTEM	Jun 15, 1988	Substantially Equivalent	American Health Products, Inc.
K880498	RM-301 PATIENT MONITOR	May 13, 1988	Substantially Equivalent	Ppg Industries, Inc.
K880066	MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR	Mar 22, 1988	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K874319	MONITOR, ELECTROGRAPHIC	Mar 07, 1988	Substantially Equivalent	Medac, Inc.
K874844	CARE TELSTAT MODELS: MP 5010 AND MP 5020	Feb 09, 1988	Substantially Equivalent	Care Systems, Inc.
K874695	HEALTHDYNE APNEA/HEART MONITOR, MODEL 900	Jan 29, 1988	Substantially Equivalent	Healthdyne, Inc.
K872443	COMPANION 50 REGULATOR/FLOWMETER	Jul 21, 1987	Substantially Equivalent	Puritan Bennett Corp.
K872354	SERIES 2000 BEDSIDE PATIENT MONITOR	Jul 21, 1987	Substantially Equivalent	Marquette Electronics, Inc.
K872249	SIRECUST MODEL 960 AND 961 PATIENT MONITORING	Jul 21, 1987	Substantially Equivalent	Medical Electronics Laboratories, Inc.
K871149	DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER	Jun 05, 1987	Substantially Equivalent	Iontec Corp.
K864748	PM-8 HEART RATE MONITOR	Mar 20, 1987	Substantially Equivalent	Pulse Time Products, Ltd.
K863494	NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20	Dec 22, 1986	Substantially Equivalent	Advantage Medical Systems, Inc.
K863466	M700 STRESS MONITOR	Dec 22, 1986	Substantially Equivalent	Kone Instruments, Inc.
K862463	LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC	Dec 05, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K850449	DIGITAL PULSE METER HRM-100E & ETC.	Dec 04, 1986	Substantially Equivalent	Sanyo Electric, Inc.
K863534	LIFE-WATCH MONITOR LT-8	Nov 21, 1986	Substantially Equivalent	Computerized Medical Systems, Inc.
K861621	CARDIAN II CR45A	Sep 12, 1986	Substantially Equivalent	Cardiac Recorders, Ltd.
K854847	PHYSIO-DYNE ECG/HR 3	Jun 16, 1986	Substantially Equivalent	Physio-Dyne Industrument Corp.
K854493	ERG 555 COUCH ERGOMETER	Jun 16, 1986	Substantially Equivalent	Robert Bosch Corp.
K854492	ERG 551 ERGOMETER, BICYCLE	Jun 16, 1986	Substantially Equivalent	Robert Bosch Corp.
K854491	ERG 550 ERGOMETER BICYCLE	Jun 16, 1986	Substantially Equivalent	Robert Bosch Corp.
K853953	CARDIOCAP MONITOR	Jun 02, 1986	Substantially Equivalent	Instrumentarium Corp.
K854597	VICKERS MEDICAL MODEL 271 HEART RATE MONITOR	May 09, 1986	Substantially Equivalent	Vickers , Ltd.
K854639	BIOMECCA CENTRAL CS1	Apr 17, 1986	Substantially Equivalent	Biomecca Australia , Ltd.
K855125	PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM	Mar 26, 1986	Substantially Equivalent	Honeywell, Inc.
K854198	PE-3000 PULSE RATE MONITOR	Mar 13, 1986	Substantially Equivalent	Quantum Life Systems, Inc.
K854881	SIRECUST 341 AND 341R	Mar 11, 1986	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K853318	PATIENT MONITOR PB240	Mar 11, 1986	Substantially Equivalent	Puritan Bennett Corp.
K853757	MOLDTEC STIMULATOR	Feb 28, 1986	Substantially Equivalent	Moldtec, Inc.
K854041	CD-100 CARDIAC MONITOR	Jan 07, 1986	Substantially Equivalent	Cardio Display Corp.
K853673	CARDIORATER CR 51	Dec 11, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K852910	CARDIORATER CR7	Nov 19, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K852887	CR5 CARDIAC MONITOR	Nov 14, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K851916	VSM MODELS A & B	Aug 19, 1985	Substantially Equivalent	Physio-Control Corp.
K840717	ECS 502	Aug 19, 1985	Substantially Equivalent	Robert Bosch Corp.
K851335	COACH TM- THE AEROBIC FITNESS MONITOR	Jul 24, 1985	Substantially Equivalent	Biotechnology, Inc.
K843533	CARDIAC EVENT RECORDER	Jun 28, 1985	Substantially Equivalent	Cryo2 Corp.
K850619	BEDSIDE PATIENT MONITOR W/MODULES	Jun 06, 1985	Substantially Equivalent	Midwest Analog & Digital, Inc.
K842817	MODEL 78353B	Jun 06, 1985	Substantially Equivalent	Hewlett-Packard Co.
K851325	MICROCOR ECG MONITOR	May 21, 1985	Substantially Equivalent	Microcor, Inc.
K850135	MEDWATCH 400 CARDIAC CENTRAL NURSES STATION	May 16, 1985	Substantially Equivalent	Medwatch Systems, Inc.
K844731	KONTRON SUPERMON 7210 PATIENT MONITOR	May 16, 1985	Substantially Equivalent	Kontron Instruments, Inc.
K850880	HORIZON 1000 CARDIAC MONITOR	Apr 25, 1985	Substantially Equivalent	Mennen Medical, Inc.
K850407	NEONATAL MONITOR 309	Apr 18, 1985	Substantially Equivalent	Rigel Medical Electronics, Inc.
K844187	SIEMENS SIRECUST 404N NEONATAL MONITOR	Apr 11, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K844215	KONTRON MINIMON 7134 PATIENT MONITOR	Apr 04, 1985	Substantially Equivalent	Kontron Instruments, Inc.
K844733	KONTRON MINIMON 7131 PATIENT MONITOR	Mar 27, 1985	Substantially Equivalent	Kontron Instruments, Inc.
K844732	KONTRON MINIMON 7132 PATIENT MONITOR	Mar 27, 1985	Substantially Equivalent	Kontron Instruments, Inc.
K850156	ECG PATIENT MONITOR 301	Mar 01, 1985	Substantially Equivalent	Rigel Medical Electronics, Inc.
K850155	ECG PATIENT MONITOR 302	Mar 01, 1985	Substantially Equivalent	Rigel Medical Electronics, Inc.
K842037	LS 5	Mar 01, 1985	Substantially Equivalent	Life Science Instrumentation, Inc.
K850114	C/PES 9201, ECG STRESS TESTING SYS	Feb 22, 1985	Substantially Equivalent	Gould, Inc.
K850113	C/PES 9103, ECG STRESS TESTING SYSTEM	Feb 08, 1985	Substantially Equivalent	Gould, Inc.
K850043	CARDIOGUARD STRESS TEST MONITOR 4002	Feb 08, 1985	Substantially Equivalent	Del Mar Avionics
K844888	SPACELABS SERIES 600 PATIENT MONITORS	Feb 01, 1985	Substantially Equivalent	Spacelabs, Inc.
K844911	ARRHYTHMIA CENTRAL-OGP-7201	Jan 18, 1985	Substantially Equivalent	Nihon Kohden America, Inc.
K842236	PATIENT MONITOR 78354A	Jan 18, 1985	Substantially Equivalent	Hewlett-Packard Co.
K843376	ECG PATIENT MONITOR	Dec 27, 1984	Substantially Equivalent	Rigel Medical Electronics, Inc.
K842582	CARE 5000 CENTRAL MONITOR MS5220 ETC.	Dec 11, 1984	Substantially Equivalent	Care Monitoring Systems
K844348	DYNASCOPE MONITOR DS-800	Dec 04, 1984	Substantially Equivalent	Fukuda Denshi USA, Inc.
K840523	SERVOMED PULSE AMPLIFIER MODULE-206-	Oct 29, 1984	Substantially Equivalent	Litton Medical Electronics
K840524	SERVOMED BASIC BEDSIDE UNIT SMV 110TP	Oct 26, 1984	Substantially Equivalent	Litton Medical Electronics
K833689	DIASCOPE 2	Oct 26, 1984	Substantially Equivalent	S & W Medico Teknik
K841363	HEART RATE/RESPIRATION SIMULATOR 8310	Oct 02, 1984	Substantially Equivalent	Aequitron Medical, Inc.
K840832	SERVOMED OXCARDIORE SPIROGRAPH 324/111	Sep 20, 1984	Substantially Equivalent	Litton Medical Electronics
K842462	HOLTER SCREENING MONITOR HS-221	Sep 11, 1984	Substantially Equivalent	Advantage Medical Systems, Inc.
K833594	FUKUDA DENSHI FX-302 AUTO/THREE CHAN	Sep 11, 1984	Substantially Equivalent	Brentwood Instruments, Inc.
K841502	LIFESCOPE 6 OEC-6105	Aug 28, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K841501	LIFESCOPE 6 OEC-6102	Aug 28, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K841499	LIFESCOPE II	Aug 28, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K840055	DYNASCOPE SERIES	Aug 22, 1984	Substantially Equivalent	Fukuda Denshi USA, Inc.
K842321	AIR SHIELDS AS461 MONITORING SYS	Aug 03, 1984	Substantially Equivalent	Air-Shields, Inc.
K840525	SERVOMED COMPACT MONITOR SMK 155-1/101	Jun 01, 1984	Substantially Equivalent	Litton Medical Electronics
K840521	SERVOMED DIGITAL DISPLAY MODULE	Jun 01, 1984	Substantially Equivalent	Litton Medical Electronics
K834600	RECOMB ECG PREAMPLIFIER/206 069 03	Jun 01, 1984	Substantially Equivalent	Litton Medical Electronics
K834530	EXTENSION BOX EB200	Jun 01, 1984	Substantially Equivalent	Honeywell, Inc.
K832250	SERVOMED BASIC BEDSIDE UNIT SMA 102-	Jun 01, 1984	Substantially Equivalent	Litton Medical Electronics
K840560	NEONATAL PHYSIOLOGICAL MONITOR 903	Apr 17, 1984	Substantially Equivalent	Novametrix Medical Systems, Inc.
K832095	SEVOMED COMPACT MONITOR SMK 154-	Mar 22, 1984	Substantially Equivalent	Litton Medical Electronics
K832025	SERVOMED COMPACT MONITOR SMK 155-7/101	Mar 22, 1984	Substantially Equivalent	Litton Medical Electronics
K840251	PATIENT MONITOR 78534B	Feb 27, 1984	Substantially Equivalent	Hewlett-Packard Co.
K833552	TREND PROCESSOR OPTION FOR #515 NEONAT	Jan 27, 1984	Substantially Equivalent	Ge Medical Systems Information Technologies
K832724	ACTIMETER UB-103	Dec 22, 1983	Substantially Equivalent	Copal, Inc.
K831164	PATIENT MONITOR CM 135	Dec 01, 1983	Substantially Equivalent	Honeywell, Inc.
K832131	SERVOMED CENTRAL STATION SMV 206	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K832035	SERVOMED COMPACT MONITOR SMK 155-9	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K832021	SERVOMED COMPACT MONITOR SMK 154-8/101	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K832018	SERVOMED COMPACT MONITOR 181/10105002	Oct 31, 1983	Substantially Equivalent	Litton Medical Electronics
K831818	CENTRAL STATION MONITOR CSM-100	Oct 31, 1983	Substantially Equivalent	Honeywell, Inc.
K831817	PATIENT MONITOR #RM-100	Oct 31, 1983	Substantially Equivalent	Honeywell, Inc.
K832041	SERVOMED STANDARD SMS 104	Oct 26, 1983	Substantially Equivalent	Litton Medical Electronics
K832026	SERVOMED BASIC BEDSIDE UNIT SMS 108 W/	Oct 26, 1983	Substantially Equivalent	Litton Medical Electronics
K832024	SERVOMED BASIC BEDSIDE UNIT - VARIOUS	Oct 26, 1983	Substantially Equivalent	Litton Medical Electronics
K832016	LME HEART-RATE MONITOR	Oct 26, 1983	Substantially Equivalent	Litton Medical Electronics
K831944	PATIENT MONITOR #78832A	Oct 19, 1983	Substantially Equivalent	Hewlett-Packard Co.
K831943	PATIENT MONITOR 788 33A	Oct 19, 1983	Substantially Equivalent	Hewlett-Packard Co.
K831428	AS 1740 INTERFACE MODULE	Oct 14, 1983	Substantially Equivalent	Narco Scientific
K831787	PATIENT MONITOR #78353A	Sep 29, 1983	Substantially Equivalent	Hewlett-Packard Co.
K831752	BIOCHECK PEC-108 PROGRAM-PULSE MONITOR	Sep 29, 1983	Substantially Equivalent	Biotechnology, Inc.
K831430	AIR SHIELDS AS-100 MONIORING SYS-AS105	Sep 12, 1983	Substantially Equivalent	Narco Scientific
K831578	PHYSIOLOGICAL MONITOR #902	Aug 12, 1983	Substantially Equivalent	Novametrix Medical Systems, Inc.
K830916	VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR	Jul 07, 1983	Substantially Equivalent	Bib, Inc.
K830885	GOULD MODEL IM3000-IM3100 BATTERY POWER	Jun 22, 1983	Substantially Equivalent	Gould, Inc.
K830517	CENTRAL STATION DISPLAY/RECORDER MATRIX	Jun 15, 1983	Substantially Equivalent	Marquette Electronics, Inc.
K830587	VITAL SIGNS MONITOR 2	Jun 08, 1983	Substantially Equivalent	Physio-Control Corp.
K823904	MODEL 515 NEO-TRAK NEONATAL MONITOR	May 25, 1983	Substantially Equivalent	Ge Medical Systems Information Technologies
K830795	CABINET FOR MULTIPLE FUNCTION BLOCKS	May 18, 1983	Substantially Equivalent	Electronics For Medicine, Inc.
K830779	PRESSURE FUNCTION BLOCK FOR BLOOD PRESS	May 09, 1983	Substantially Equivalent	Honeywell, Inc.
K830282	ELECTRONIC EXERCISE #313-PULSE RATE	Apr 14, 1983	Substantially Equivalent	Walton Manufacturer Co.
K830433	PATIENT MONITOR 575	Mar 24, 1983	Substantially Equivalent	Kone Instruments, Inc.
K830432	CENTRAL STATION 590	Mar 24, 1983	Substantially Equivalent	Kone Instruments, Inc.
K823290	NEUROMEDICS PACETRON HEART RATE MONITOR	Dec 30, 1982	Substantially Equivalent	Intermedics, Inc.
K823197	MODEL 8300 TESTER	Dec 30, 1982	Substantially Equivalent	Medicon, Inc.
K823312	CADIO-RESPIRATORY MONITOR #CR-2	Nov 30, 1982	Substantially Equivalent	Electromed Intl., Ltd.
K822952	560	Nov 01, 1982	Substantially Equivalent	Kone Instruments, Inc.
K822876	MODEL 78534A PATIENT MONITOR	Oct 18, 1982	Substantially Equivalent	Hewlett-Packard Co.
K822695	SIGNAL DISTRIBUTION NETWORK #78581A	Oct 15, 1982	Substantially Equivalent	Hewlett-Packard Co.
K822692	DIGITAL PULSE METER (73 BWS) #HRM-100E	Oct 15, 1982	Substantially Equivalent	Sanyo Electric, Inc.
K822615	LIFE WATCH LSI	Sep 21, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K822390	LIFE TRACE 24	Sep 21, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K822389	LIFE TRACE 40/42	Sep 21, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K822319	RE1000 HEART RATE MONITOR	Sep 14, 1982	Substantially Equivalent	Electronic Monitors, Inc.
K822388	LIFE TRACE 14	Aug 24, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K821942	HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85	Aug 24, 1982	Substantially Equivalent	Harvey-Bostwick, Inc.
K821959	CARDIO-RESPIRATORY MONITOR MODEL CR-1	Jul 20, 1982	Substantially Equivalent	Electromed Intl., Ltd.
K821755	TELCOR 2	Jul 02, 1982	Substantially Equivalent	Burdick Corp.
K821720	PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000	Jun 25, 1982	Substantially Equivalent	Novametrix Medical Systems, Inc.
K821223	CR-9	Jun 17, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K821368	MODELS 78504A & 78508A PATIENT MON. SYS	May 25, 1982	Substantially Equivalent	Hewlett-Packard Co.
K821015	CARE MODEL IP 4500 AUTO SCANNERR	May 24, 1982	Substantially Equivalent	Care Monitoring Systems
K820825	CARDIAC MONITOR - RATE ALARM	Apr 15, 1982	Substantially Equivalent	Hewlett-Packard Co.
K820745	DIASCOPE 2	Apr 01, 1982	Substantially Equivalent	Puritan Bennett Corp.
K820671	CM10 CENTRAL MONITORING SYSTEM	Apr 01, 1982	Substantially Equivalent	Medtel Pty. , Ltd.
K820540	OLLI 565	Apr 01, 1982	Substantially Equivalent	Kone Instruments, Inc.
K820399	HS20 PORT. OPERATING ROOM MONITOR	Mar 22, 1982	Substantially Equivalent	Medtel Pty. , Ltd.
K820417	#506 PORT. VITAL FUNCTIONS NEONATAL MON	Mar 04, 1982	Substantially Equivalent	Ge Medical Systems Information Technologies
K820416	#505 PORT. VITAL FUNCTIONS NEONATAL MON	Mar 04, 1982	Substantially Equivalent	Ge Medical Systems Information Technologies
K820114	SYSTEM V.HEART RATE/RESPIR. RATE MONIT.	Feb 12, 1982	Substantially Equivalent	Narco Air-Shields
K813174	BRADYCARDIA ALARM	Jan 22, 1982	Substantially Equivalent	Douglas Scientific Products
K813444	NIHON KOHDEN HEART MONITORS OMP 7101-02	Dec 29, 1981	Substantially Equivalent	Nihon Kohden America, Inc.
K812828	MODEL 2000 MONITOR	Nov 16, 1981	Substantially Equivalent	Datascope Corp.
K812674	INFANT CARIDAC MONITOR	Oct 13, 1981	Substantially Equivalent	Electromed Intl., Ltd.
K812147	CARDIORATER CR-7	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812146	CARDIORATER CR-5	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812145	CARDIORATER CR-3	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812144	CENTERAL MONITOR 360	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812131	PORTAPULSE	Sep 21, 1981	Substantially Equivalent	Gavon, Inc.
K811425	CARDIACMONITORS	Sep 16, 1981	Substantially Equivalent	Pulse Time Products, Ltd.
K811893	NOVAMETRIX PHYSIOLOGICAL MONITOR #910	Sep 08, 1981	Substantially Equivalent	Novametrix Medical Systems, Inc.
K812271	CENTRAL STATION MONITOR	Aug 31, 1981	Substantially Equivalent	Datascope Corp.
K811216	RESIDENT BEDSIDE MONITOR	Jul 02, 1981	Substantially Equivalent	Abbott Laboratories
K810755	SQUINN VITATEK 500 SERIES PHYSIOL. MONI	Apr 03, 1981	Substantially Equivalent	Vitatek
K803223	ADVANCMED ELIMINATOR	Jan 13, 1981	Substantially Equivalent	American Edwards Laboratories
K802782	THE CRITERION II PACING SYS. MONITOR	Nov 19, 1980	Substantially Equivalent	Dart Medical Equipment
K802182	WISCONSIN HEART RATE MONITOR	Oct 31, 1980	Substantially Equivalent	Lunar Radiation Corp.
K802325	CRITERION II PACING SYSTEM MONITORS	Oct 23, 1980	Substantially Equivalent	Dart Medical Equipment
K802204	CT-1600 DIGITAL PULSE RATE MONITOR	Oct 03, 1980	Substantially Equivalent	Industrial & Biomedical Sensors Corp.
K802184	HS10 PORTABLE OPERATING ROOM MONITOR	Sep 26, 1980	Substantially Equivalent	Medtel Pty. , Ltd.
K800519	HEARTWATCH	Sep 26, 1980	Substantially Equivalent	D. Jenkins
K801761	PDS COMPUTER UNIT/VIDEO TERMINAL	Aug 20, 1980	Substantially Equivalent	General Electric Co.
K800405	A-V MINI CLINIC	Jul 21, 1980	Substantially Equivalent	Instromedix, Inc.
K801515	ABBY II PATIENT MONITOR OR VITAL SIGNS M	Jul 08, 1980	Substantially Equivalent	Abbott Medical Electronics Co.
K800243	D668 & D664 CENTRAL MONITORING SYSTEMS	Apr 10, 1980	Substantially Equivalent	Medtel Pty. , Ltd.
K800500	PULSEOMETER	Apr 08, 1980	Substantially Equivalent	Kirklands Sporting Goods Co.
K792226	CARDIVAN BLOOD PRESSURE MONITOR	Dec 19, 1979	Substantially Equivalent	Paramed Technology, Inc.
K792122	CHRONAEROBIC (CA-1)	Nov 27, 1979	Substantially Equivalent	Stanford Scientific, Inc.
K792312	HEART RATE MONITOR MD-1	Nov 21, 1979	Substantially Equivalent	Medical Devices, Inc.
K792117	AIR-SHIELDS HEART RATE MONITOR	Nov 13, 1979	Substantially Equivalent	Narco Air-Shields
K791862	HEART RATE COMPUTER	Oct 04, 1979	Substantially Equivalent	Stanford Assoc., Inc.
K790545	STRESS TESTING SYSTEM, LATERAL TILTING	Jun 06, 1979	Substantially Equivalent	Engineering Dynamics Corp.
K790544	STRESS TESTING SYSTEM, MULTI-POSITION	Jun 05, 1979	Substantially Equivalent	Engineering Dynamics Corp.
K790552	AS7 & AS8 MONITORS	May 01, 1979	Substantially Equivalent	Narco Air-Shields
K790644	SUBMAX	Apr 26, 1979	Substantially Equivalent	Chase Mfg. Co.
K790506	DAISCOPE & ACCESSORIES	Apr 09, 1979	Substantially Equivalent	Simonsen & Weels Eftf.
K790454	MODEL 78801A PATIENT MONITORS	Apr 03, 1979	Substantially Equivalent	Hewlett-Packard Co.
K790198	MONITOR PLUG-IN MODEL M1106 ECG	Mar 06, 1979	Substantially Equivalent	Electronics For Medicine, Inc.
K790004	MONITOR SCOPES, MODELS 9502, 9503	Feb 28, 1979	Substantially Equivalent	C-V Monitors Corp.
K790292	MONITOR, ELECTROCARDIOSCOPE	Feb 26, 1979	Substantially Equivalent	Burdick Corp.
K782131	PULSETAKER	Jan 15, 1979	Substantially Equivalent	Van, Cott, Bagley, Cornwall & Mccarth
K782089	MONITOR, HEART RATE MODEL 103	Jan 04, 1979	Substantially Equivalent	Roche Medical Electronics, Inc.
K782088	MONITOR, HEART RATE MODEL 105	Jan 04, 1979	Substantially Equivalent	Roche Medical Electronics, Inc.
K781166	MONITOR, HEART RATE	Oct 15, 1978	Substantially Equivalent	Cybernetic Medical, Inc.
K781407	ERM-101	Sep 27, 1978	Substantially Equivalent	Cynergy
K781387	INSTA-PULSE HEART RATE MONITOR	Sep 20, 1978	Substantially Equivalent	Bio Sig Instruments, Inc.
K781292	CARDIOPNEUMOGRAPH	Sep 20, 1978	Substantially Equivalent	Street Electronics Corp.
K781255	DIGITAL PANEL METER	Sep 20, 1978	Substantially Equivalent	Rae Medical Corp.
K780937	MODEL 20 DIGITAL PULSE RATE MONITOR	Aug 31, 1978	Substantially Equivalent	Sentronix, Inc.
K780445	LIQUID CRYSTAL DISPLAY DIGITAL WATCH	Jun 19, 1978	Substantially Equivalent	Hughes Aircraft Co.
K780702	CSS-60 DIGITAL HEART RATE METER	May 19, 1978	Substantially Equivalent	Burdick Corp.
K780297	CARDIAC MINISCOPE & MINIGRAPH	May 19, 1978	Substantially Equivalent	Arco Medical Products Co.
K780404	ECG MONITORING SYSTEM,	Mar 28, 1978	Substantially Equivalent	Quinton, Inc.
K772332	MONITOR, CARDIAC, BEDSIDE	Feb 13, 1978	Substantially Equivalent	Telectronics, Inc.
K780117	CARDIOMETER	Feb 03, 1978	Substantially Equivalent	Med General
K772006	ACUTE CARDIAC CARE SYSTEM	Nov 28, 1977	Substantially Equivalent	Physio-Control Corp.
K772097	HEARTRATE METER MODEL 650, P/N 000119	Nov 22, 1977	Substantially Equivalent	Quinton, Inc.
K772056	PHYSIOLOGICAL MONITOR MODEL 871	Nov 22, 1977	Substantially Equivalent	Datascope Corp.
K772053	LINE CHARGER MODEL LC-100	Nov 09, 1977	Substantially Equivalent	Datascope Corp.
K771360	ECG SCOPE MODEL 7833	Aug 04, 1977	Substantially Equivalent	Hewlett-Packard Co.
K771199	SURGIPULSE HEART RATE MONITOR	Jul 25, 1977	Substantially Equivalent	Stryker Corp.
K770024	MONITOR, NEONATAL, MODEL 78260A	Feb 28, 1977	Substantially Equivalent	Hewlett-Packard Co.
K770023	MONITOR, NEONATE, MODEL 78213A	Feb 28, 1977	Substantially Equivalent	Hewlett-Packard Co.
K770022	MONITOR, NEONATAL, MODEL 78261A	Feb 28, 1977	Substantially Equivalent	Hewlett-Packard Co.
K770239	DIGITAL HEART RATE METER	Feb 14, 1977	Substantially Equivalent	Burdick Corp.
K770038	MONITOR, HEARTWATCH HEART RATE	Jan 14, 1977	Substantially Equivalent	Respironics, Inc.
K761291	CENTRAL STATION MONITORING SYSTEM	Dec 28, 1976	Substantially Equivalent	Abbott Laboratories
K761076	DEMODULATOR/CARDIOTACHOMETER	Dec 28, 1976	Substantially Equivalent	Eldeco
K761211	MODEL 15050A DIGITAL DISPLAY	Dec 13, 1976	Substantially Equivalent	Hewlett-Packard Co.
K760710	PULSAR PULSE MONITOR WATCH	Dec 02, 1976	Substantially Equivalent	Time Computer, Inc. (Tci)
K760803	PHYSIOLOGICAL MONITOR (MODEL 870)	Oct 20, 1976	Substantially Equivalent	Datascope Corp.
K760593	PORTABLE CARDIAC MONITOR, ABBY	Sep 16, 1976	Substantially Equivalent	Abbott Laboratories
K760120	PULSE CARDULE (MODEL 1859/1860 ECG)	Jul 20, 1976	Substantially Equivalent	Spacelabs, Inc.
K760160	MONITOR, PATIENT (MODEL 78333A)	Jul 19, 1976	Substantially Equivalent	Hewlett-Packard Co.