Product Code: MHX FDA class 2 21 CFR 870.1025

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Cardiovascular

The Patient Physiological Monitor with Arrhythmia Detection or Alarms is a device that continuously measures and displays one or more physiological parameters such as heart rate, blood pressure, or oxygen saturation, and includes automated detection algorithms or alert systems to notify clinicians of cardiac arrhythmias or other abnormal conditions. It is classified as a Class 2 device under 21 CFR 870.1025, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, and is overseen by the Cardiovascular specialty panel. It is subject to general and special controls and does not carry implant or life-sustaining flags.

View on FDA

510(k)s

425

FEI Numbers

121

Registration Numbers

121

Unique Applicants

115

Years Active

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Basic Information

Product Code: MHX
Device Class: FDA class 2
Regulation Number: 870.1025
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 425 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254209	Radius VSM and Accessories	Jun 04, 2026	Substantially Equivalent	Masimo Corporation
K252840	M12 Telemetry System	May 29, 2026	Substantially Equivalent	Global Instrumentation, LLC
K260098	ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)	May 20, 2026	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K250349	Vista CMS	Apr 24, 2026	Substantially Equivalent	Shanghai Draeger Medical Instrument Co., Ltd.
K253170	uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors	Apr 16, 2026	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K252250	Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)	Apr 10, 2026	Substantially Equivalent	Shanghai Draeger Medical Instrument Co., Ltd.
K252726	IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)	Feb 06, 2026	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K252589	Corvair Monza	Jan 09, 2026	Substantially Equivalent	AliveCor, Inc.
K250854	Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)	Dec 17, 2025	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd
K251702	IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )	Nov 10, 2025	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K251146	IntelliVue Patient monitors MX400, MX450, MX500, MX550	Oct 17, 2025	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K250453	IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)	Sep 02, 2025	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K250179	Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)	Jul 29, 2025	Substantially Equivalent	Edan Instruments, Inc.
K242562	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	Jul 09, 2025	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K250757	Radius VSM and Accessories	May 29, 2025	Substantially Equivalent	Masimo Corporation
K242962	Telemetry Monitor 5500 Release 4.0 (867232)	May 05, 2025	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K240312	Infinity CentralStation Wide	Aug 01, 2024	Substantially Equivalent	Draeger Medical Systems, Inc.
K240320	Patient Monitor (RespArray)	Jun 28, 2024	Substantially Equivalent	Edan Instruments, Inc.
K231010	Corvair	Jun 07, 2024	Substantially Equivalent	AliveCor, Inc.
K232962	Patient Monitor (iX10, iX12, iX15)	Apr 19, 2024	Substantially Equivalent	Edan Instruments, Inc.
K232694	Central Monitoring System (MFM-CMS)	Feb 05, 2024	Substantially Equivalent	Edan Instruments, Inc.
K231671	IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)	Dec 19, 2023	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K230604	IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)	Nov 22, 2023	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K231477	Infinity CentralStation Wide, Infinity M300, Infinity M300+	Oct 17, 2023	Substantially Equivalent	Draeger Medical Systems, Inc.
K223574	IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)	Aug 22, 2023	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K221056	ARGUS PB-3000	Jul 06, 2023	Substantially Equivalent	Schiller AG
K223498	Radius VSM and Accessories	Jun 01, 2023	Substantially Equivalent	Masimo Corporation
K223531	CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)	Apr 06, 2023	Substantially Equivalent	GE Healthcare Finland Oy
K221348	IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)	Feb 03, 2023	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K211619	Multi-Parameter Patient Monitor	Dec 29, 2022	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd
K222586	Mural Clinical Viewer	Dec 21, 2022	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K221904	EK12 V2 Algorithm	Dec 20, 2022	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K220308	Patient Monitor: RespArray	Aug 11, 2022	Substantially Equivalent	Edan Instruments, Inc.
K221879	Patient Monitor, models LM-8, LM-10, LM-12 and LM-15	Aug 10, 2022	Substantially Equivalent	Caf Medical Solutions, Inc.
K221616	Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17	Aug 01, 2022	Substantially Equivalent	Caf Medical Solutions, Inc.
K220989	Next Generation NetKonnect	Jul 29, 2022	Substantially Equivalent	Nihon Kohden Digital Health Solutions, Inc.
K213799	N Series Patient Monitors	Jul 12, 2022	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K213363	CARESCAPE B450, E-musb	Apr 13, 2022	Substantially Equivalent	GE Healthcare Finland Oy
K213336	Carescape B850, E-musb	Apr 13, 2022	Substantially Equivalent	GE Healthcare Finland Oy
K213181	CARESCAPE B650, E-musb	Apr 13, 2022	Substantially Equivalent	GE Healthcare Finland Oy
K213234	CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201	Apr 12, 2022	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K213490	Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P	Apr 01, 2022	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K211900	Patient Information Center iX	Mar 04, 2022	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K203088	Infinity Acute Care System (IACS) Monitoring System	Feb 01, 2022	Substantially Equivalent	Draeger Medical Systems, Inc.
K201764	Infinity Acute Care System (IACS) Monitoring Solution	Dec 09, 2021	Substantially Equivalent	Draeger Medical Systems, Inc.
K210906	IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4	Oct 07, 2021	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K203435	Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System	Jul 16, 2021	Substantially Equivalent	Nihon Kohden Corporation
K202336	Patient Monitor	Jan 23, 2021	Substantially Equivalent	Edan Instruments, Inc.
K202405	BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1	Jan 07, 2021	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K201941	Monitor B125, Monitor B105	Nov 04, 2020	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K201746	Tempus Pro Patient Monitor	Sep 18, 2020	Substantially Equivalent	Remote Diagnostic Technologies Limited
K192137	IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550	Sep 11, 2020	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K200859	Infinity M300	Aug 28, 2020	Substantially Equivalent	Draeger Medical Systems, Inc.
K200015	ePM Series Patient monitors	Jun 08, 2020	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K192972	Patient Monitor	May 07, 2020	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K192514	Patient Monitor	Apr 02, 2020	Substantially Equivalent	Edan Instruments, Inc.
K200494	CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES	Mar 29, 2020	Substantially Equivalent	GE Healthcare
K191323	Carescape B850	Jan 29, 2020	Substantially Equivalent	GE Healthcare Finland Oy
K191249	CARESCAPE B450	Jan 24, 2020	Substantially Equivalent	GE Healthcare Finland Oy
K191149	CARESCAPE B650	Jan 21, 2020	Substantially Equivalent	GE Healthcare Finland Oy
K190008	Carescape One	Dec 20, 2019	Substantially Equivalent	GE Healthcare
K190939	ZOLL Arrhythmia Management Sysyem	Dec 19, 2019	Substantially Equivalent	Zoll Manufacturing Corporation
K191106	C50 and C80 Multi-parameter Patient Monitor	Dec 13, 2019	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd
K182979	IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3	Nov 19, 2019	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K191769	ePM Series Patient monitors	Oct 31, 2019	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K183387	M3290B Patient Information Center iX	Aug 06, 2019	Substantially Equivalent	Philips Medical Systems
K190011	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	Jul 10, 2019	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K173036	North-vision Multi-parameter Patient Monitor	Dec 21, 2018	Substantially Equivalent	North-Vision Tech., Inc.
K182075	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	Dec 10, 2018	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K180482	ZOLL Propaq M	Nov 30, 2018	Substantially Equivalent	ZOLL Medical Corporation
K181831	IntelliVue Multi-Measurement Module MMX	Nov 15, 2018	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K181314	IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension	Sep 04, 2018	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K173765	Surveyor Patient Monitor	Sep 04, 2018	Substantially Equivalent	Mortara Instrument, Inc.
K173454	Multi-parameter Patient Monitor, models C30	Aug 16, 2018	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd
K180017	MX40 Release C.01	Jul 24, 2018	Substantially Equivalent	Philips Medical Systems
K180472	ViSi Mobile Monitoring System	Jun 19, 2018	Substantially Equivalent	Sotera Wireless, Inc.
K172510	µCor Heart Failure and Arrhythmia Management System	May 11, 2018	Substantially Equivalent	Zoll Manufacturing Corporation
K173768	Tempus Pro Patient Monitor	Jan 10, 2018	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.
K172966	CMS-2000 Central Monitoring System	Dec 08, 2017	Substantially Equivalent	Advanced Instumentations, Inc.
K171901	uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)	Nov 15, 2017	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K172226	MX40 Release B.07	Nov 09, 2017	Substantially Equivalent	Philips Medical Systems
K171580	Monitor B125, Monitor B105	Nov 01, 2017	Substantially Equivalent	Ge Medical Systems (China) Co., Ltd.
K171801	IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable	Oct 06, 2017	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K170876	Passport Series Patient Monitors(Passport 12m, Passport 17m)	Aug 23, 2017	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K163584	M3290B Philips IntelliVue Information Center iX	Jul 07, 2017	Substantially Equivalent	Philips Medical Systems
K170567	Tempus Pro Patient Monitor	Jul 06, 2017	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.
K171621	Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor	Jun 30, 2017	Substantially Equivalent	Welch Allyn, Inc.
K170155	EK12 Algorithm	Jun 06, 2017	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K170514	Central Monitoring System	May 24, 2017	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.
K163459	Nihon Kohden Vital Sign Telemeter	Apr 04, 2017	Substantially Equivalent	Nihon Kohden Corporation
K161056	Telemetry Transmitter	Feb 03, 2017	Substantially Equivalent	Edan Instruments, Inc.
K161517	Mortara Surveyor Patient Monitor	Jan 11, 2017	Substantially Equivalent	Mortara Instrument, Inc.
K160981	Patient Monitor	Dec 22, 2016	Substantially Equivalent	Edan Instruments, Inc.
K153707	Nihon Kohden Vital Sign Telemeter	Sep 02, 2016	Substantially Equivalent	Nihon Kohden Corporation
K160685	Surveyor S4 Mobile Monitor	Aug 04, 2016	Substantially Equivalent	Mortara Instrument, Inc.
K161531	IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800	Jul 01, 2016	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K153702	M3290B Philips IntelliVue Information Center iX	Jun 13, 2016	Substantially Equivalent	Philips Medical Systems
K160951	Philips Efficia CMS200 Central Monitoring System	May 05, 2016	Substantially Equivalent	Philips Medical Systems
K152973	Dyna-Vision Telemonitoring System	Apr 29, 2016	Substantially Equivalent	Techmedic Development International B.V.
K152552	Patient Monitor	Apr 29, 2016	Substantially Equivalent	Edan Instruments, Inc.
K153160	AVIVO Mobile Patient Management (MPM) System	Mar 30, 2016	Substantially Equivalent	Medtronic, Inc.
K153448	Passport Series Patient Monitors (Including Passport 8, Passport 12)	Mar 03, 2016	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K153275	Aingeal Activity System	Feb 26, 2016	Substantially Equivalent	Intelesens, Ltd.
K152902	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	Feb 18, 2016	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K151812	PATIENT MONITORS VARIOUS MODELS	Jan 26, 2016	Substantially Equivalent	Philips Medical Systems
K151063	Monitor B40	Dec 15, 2015	Substantially Equivalent	Ge Medical Systems China Co., Ltd.
K151080	Nihon Kohden CSM 1901 Bedside Monitor	Nov 05, 2015	Substantially Equivalent	Nihon Kohden
K150329	elance Vital Signs Monitor, Central Monitor Software	Nov 05, 2015	Substantially Equivalent	Spacelabs Healthcare
K151027	zensor system	Oct 02, 2015	Substantially Equivalent	Intelesens Limited
K152407	Infinity Delta, Infinity Delta XL, Infinity Kappa	Sep 23, 2015	Substantially Equivalent	Draeger Medical Sytems, Inc.
K151860	Infinity CentralStation Wide	Sep 02, 2015	Substantially Equivalent	Draeger Medical Systems, Inc.
K150352	V Series Monitoring System (including V12 and V21 Monitors)	Sep 02, 2015	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K150082	Panorama Patient Monitoring Network	Sep 02, 2015	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K143676	B40i Patient Monitor	Jul 31, 2015	Substantially Equivalent	GE Healthcare Finland Oy
K142827	Visi Mobile Monitoring System, Visi Mobile Chest Sensor	Jul 20, 2015	Substantially Equivalent	Sotera Wireless, Inc.
K150975	Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors	Jun 25, 2015	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K150030	Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor	Mar 16, 2015	Substantially Equivalent	Fukuda Denshi USA, Inc.
K134046	FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR	Feb 12, 2015	Substantially Equivalent	Fukuda Denshi USA, Inc.
K141963	12SL ECG ANALYSIS PROGRAM	Feb 05, 2015	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K143195	Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)	Dec 22, 2014	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
K141811	MORTARA MONITORING WAVEFORM VIEWER	Nov 19, 2014	Substantially Equivalent	Mortara Instrument, Inc.
K142601	Panorama Patient Monitoring Network	Nov 14, 2014	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co.
K141156	SPACELABS HEALTHCARE TELEMETRY RECEIVER	Sep 09, 2014	Substantially Equivalent	Spacelabs Healthcare
K133222	SAAD PATIENT MONITOR (SPM)	Aug 06, 2014	Substantially Equivalent	Hanin Medical Services Co., Ltd.
K132662	PASSPORT SERIES PATIENT MONITORS	Aug 01, 2014	Substantially Equivalent	Shenzhen Mindray Biomedical Electronics Co., Ltd.
K141015	INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT	May 19, 2014	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K132077	PATIENT MONITOR	Apr 23, 2014	Substantially Equivalent	Advanced Instrumentations, Inc.
K132075	PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)	Apr 18, 2014	Substantially Equivalent	Mindray North America
K131971	IM60/IM70 PATIENT MONITOR	Mar 20, 2014	Substantially Equivalent	Edan Instruments, Inc.
K131876	M SERIES PATIENT MONITOR	Feb 27, 2014	Substantially Equivalent	Mid-Link Consulting Co, Ltd.
K133576	MONITOR B40	Feb 21, 2014	Substantially Equivalent	Ge Medical Systems China Co., Ltd.
K130401	ALERTWATCH: OR	Feb 07, 2014	Substantially Equivalent	Alertwatch, LLC
K132026	V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21	Dec 20, 2013	Substantially Equivalent	Mindray DS USA, Inc.
K130208	BERNOULLI ENTERPRISE SOFTWARE	Dec 20, 2013	Substantially Equivalent	Cardiopulmonary Corp.
K132533	CARESCAPE MONITOR B450	Dec 04, 2013	Substantially Equivalent	GE Healthcare Finland Oy
K131929	SURVEYOR CENTRAL STATION	Dec 03, 2013	Substantially Equivalent	Mortara Instrument, Inc.
K131872	INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550	Oct 17, 2013	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K131414	CARESCAPE MONITOR B850	Aug 28, 2013	Substantially Equivalent	GE Healthcare Finland Oy
K131223	CARESCAPE MONITOR B650	Aug 28, 2013	Substantially Equivalent	GE Healthcare Finland Oy
K131829	INTELLIVUE PATIENT MONITOR	Aug 16, 2013	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K131032	PHILIPS SURESIGNS CENTRAL	Aug 12, 2013	Substantially Equivalent	Philips Medical Systems
K131763	TRUSCOPE SERIES PATIENT MONITOR	Jul 15, 2013	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.
K123074	IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS	Jul 03, 2013	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K130584	MONITOR B40	Jun 26, 2013	Substantially Equivalent	Ge Medical Systems China Co., Ltd.
K120727	MFM-CMS CENTRAL MONITORING SYSTEM	Jun 21, 2013	Substantially Equivalent	Edan Instruments, Inc.
K130849	INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450	Jun 14, 2013	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K122146	XHIBIT CENTRAL STATION, MODEL 96102	Apr 22, 2013	Substantially Equivalent	Spacelabs Healthcare
K123900	SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8	Apr 18, 2013	Substantially Equivalent	Philips Medical Systems
K130711	INFINITY CENTRALSTATION WITH INFINITY M300	Apr 11, 2013	Substantially Equivalent	Draeger Medical Systems, Inc.
K123556	MORTARA SURVEYOR PATIENT MONITOR	Mar 22, 2013	Substantially Equivalent	Mortara Instrument, Inc.
K122253	PROCARE MONITOR B20	Mar 22, 2013	Substantially Equivalent	Ge Medical Systems China Co., Ltd.
K123472	CIMVA UNIVERSAL	Mar 05, 2013	Substantially Equivalent	Therapeutic Monitoring Systems (Tms), Inc.
K123048	PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO	Jan 11, 2013	Substantially Equivalent	Advanced Instrumentations, Inc.
K122439	INTELLIVUE PATIENT MONITOR	Aug 29, 2012	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K113045	BIOHARNESS	Aug 14, 2012	Substantially Equivalent	Zephyr Technology Corporation
K120598	PROCARE MONITOR B40	Jul 19, 2012	Substantially Equivalent	Ge Medical Systems China Co., Ltd.
K120366	INTELLIVUE PATIENT MONITOR	Jul 18, 2012	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K121367	ZOLL PROPAQ XM	Jun 21, 2012	Substantially Equivalent	ZOLL Medical Corporation
K121480	ARIATELE TELEMETRY TRANSMITTER (96281)	Jun 06, 2012	Substantially Equivalent	Spacelabs Healthcare
K120631	PATIENT MONITOR	May 25, 2012	Substantially Equivalent	Advanced Instruments, Inc.
K120173	PATIENT MONITOR	May 16, 2012	Substantially Equivalent	Edan Instruments, Inc.
K120616	SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390	Mar 29, 2012	Substantially Equivalent	Spacelabs Medical, Inc.
K113798	INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET	Mar 22, 2012	Substantially Equivalent	Draeger Medical Systems, Inc.
K113657	INTELLIVUE PATIENT MONITOR	Mar 22, 2012	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K113441	PHYSIOLOGICAL MONITOR, PATIENT MONITOR	Mar 22, 2012	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K113054	EQUIVITAL	Feb 17, 2012	Substantially Equivalent	Hidalgo Limited
K113653	PATIENT MONITOR	Feb 06, 2012	Substantially Equivalent	Edan Instruments, Inc.
K113623	PATIENT MONITOR	Feb 01, 2012	Substantially Equivalent	Edan Instruments, Inc.
K113187	AVIVO MOBILE PATIENT MANAGEMENT	Jan 04, 2012	Substantially Equivalent	Corventis, Inc.
K112637	NETKONNECT REMOTE NETWORK EXTENSION	Dec 09, 2011	Substantially Equivalent	Nihon Kohden
K112190	PATIENT MONITOR	Nov 09, 2011	Substantially Equivalent	Mediana Co., Ltd.
K112962	SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)	Nov 02, 2011	Substantially Equivalent	Spacelabs Medical, Inc.
K112803	PATIENT MONITOR	Oct 24, 2011	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.
K110922	PATIENT MONITOR	Jul 20, 2011	Substantially Equivalent	Edan Instruments, Inc.
K101692	PATIENT MONITOR	Jun 28, 2011	Substantially Equivalent	Contec Medical System Co., Ltd.
K110953	VISENSIA, VISENSIA WITH ALERT	Jun 15, 2011	Substantially Equivalent	Obs Medical
K110015	VITALSENS, AINGEAL, V-POD	May 20, 2011	Substantially Equivalent	Intelesens Limited
K110622	INTELLIVUE PATIENT MONITOR	Mar 31, 2011	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K103134	FUKUDA DENSHI	Mar 11, 2011	Substantially Equivalent	Fukuda Denshi USA, Inc.
K103652	SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8	Jan 13, 2011	Substantially Equivalent	Philips Medical Systesms
K103646	INTELLIVUE MX40 PATIENT MONITOR	Jan 07, 2011	Substantially Equivalent	Phillips Medical Systems
K102422	SPACELABS MEDICAL PATIENT MONITORS	Dec 07, 2010	Substantially Equivalent	Spacelabs Medical, Inc.
K102376	NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201	Dec 07, 2010	Substantially Equivalent	Nihon Kohden Corp.
K100040	BIOHARNESS	Dec 03, 2010	Substantially Equivalent	Zephyr Technology Corporation
K101619	WELCH ALLYN 1500 PATIENT MONITOR	Nov 12, 2010	Substantially Equivalent	Schiller AG
K102562	INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800	Oct 21, 2010	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K102239	CARESCAPE MONITOR B650	Oct 18, 2010	Substantially Equivalent	GE Healthcare Finland Oy
K102495	M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0	Sep 30, 2010	Substantially Equivalent	Philips Medical Systems
K102040	PATIENT MONITOR	Sep 24, 2010	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.
K102004	ENDEAVOUR MONITORING SYSTEM	Sep 10, 2010	Substantially Equivalent	Mindray DS USA, Inc.
K092449	BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5	Aug 30, 2010	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K101521	ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O	Jul 29, 2010	Substantially Equivalent	Philips Medical Systems
K101449	INTELLIVUE PATIENT MONITOR	Jun 18, 2010	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K100217	LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30	Jun 08, 2010	Substantially Equivalent	Mediana Co., Ltd.
K093268	INTELLIVUE PATIENT MONITOR	May 11, 2010	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K101067	SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068	May 07, 2010	Substantially Equivalent	Philips Medical Systems
K100939	INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90	Apr 30, 2010	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K100046	M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000	Apr 08, 2010	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.
K093788	INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION	Mar 08, 2010	Substantially Equivalent	Draeger Medical Systems, Inc.
K092369	12SL ECG ANALYSIS PROGRAM	Feb 24, 2010	Substantially Equivalent	Ge Medical Systems Information Technologies
K092970	GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H	Feb 02, 2010	Substantially Equivalent	General Meditech, Inc.
K093501	ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION	Nov 24, 2009	Substantially Equivalent	Spacelabs Medical, Inc.
K092680	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN	Sep 23, 2009	Substantially Equivalent	GE Healthcare Finland Oy
K092027	CARESCAPE MONITOR B850	Aug 28, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies
K091594	HEART-EXERCISE	Jul 29, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies GmbH
K091834	PASSPORT V MONITOR, MODEL 0998-00-6100	Jul 15, 2009	Substantially Equivalent	Datascope Corp., Patient Monitoring Division
K091395	MP5 INTELLIVUE PATIENT MONITOR	Jun 05, 2009	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K090443	PLANET 55, MODEL 100	Jun 05, 2009	Substantially Equivalent	Larsen & Toubro Limited
K090172	STAR 55 MODEL 100	Jun 05, 2009	Substantially Equivalent	Larsen & Toubro Limited
K090556	SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE	Apr 30, 2009	Substantially Equivalent	Spacelabs Healthcare Medical Equipment (Suzhou) CO
K090702	MODIFICATION TO DASH 2500 PATIENT MONITOR	Apr 15, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies
K083750	CAPNOSTAT / CAPNOFLEX CO2 SYSTEM	Mar 23, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies
K083697	FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M	Mar 19, 2009	Substantially Equivalent	Fukuda Denshi USA, Inc.
K082583	INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5	Feb 25, 2009	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K083271	BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY	Dec 24, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K082785	NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES	Nov 26, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K083228	PHILIPS INTELLIVUE MP5 PATIENT MONITOR	Nov 24, 2008	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K081793	PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER	Oct 14, 2008	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K082280	SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR	Oct 08, 2008	Substantially Equivalent	Philips Medical Systems North America Co.
K081891	FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR	Aug 29, 2008	Substantially Equivalent	Fukuda Denshi USA, Inc.
K081983	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00	Aug 22, 2008	Substantially Equivalent	Philips Medical Systems
K082045	MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220	Aug 01, 2008	Substantially Equivalent	Spacelabs Medical, Inc.
K081140	VISENSIA	Jul 17, 2008	Substantially Equivalent	Obs Medical
K073280	BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5	Jun 23, 2008	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K080251	APEXPRO TELEMETRY SYSTEMS	Jun 20, 2008	Substantially Equivalent	Ge Medical Systems Information Technologies
K073550	PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION	Mar 28, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K080495	SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3	Mar 24, 2008	Substantially Equivalent	Philips Medical Systems
K080157	DASH 2500 PATIENT MONITOR	Mar 24, 2008	Substantially Equivalent	Ge Medical Systems Information Technologies
K080342	NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES	Feb 26, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K073462	MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES	Jan 11, 2008	Substantially Equivalent	Ge Medical Systems Information Technologies
K071164	LIFE+CEL BATTERY	Dec 07, 2007	Substantially Equivalent	Amco International Manufacturing & Design, Inc.
K073203	CARESCAPE V100	Nov 29, 2007	Substantially Equivalent	Ge Medical Systems Information Technologies
K072346	PM-7000 PATIENT MONITOR	Nov 29, 2007	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K072070	PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS	Aug 10, 2007	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K070791	PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS	Jun 26, 2007	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K071020	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE	Jun 18, 2007	Substantially Equivalent	GE Healthcare
K071426	MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS	Jun 13, 2007	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K070566	INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL	Jun 04, 2007	Substantially Equivalent	Draeger Medical Systems, Inc.
K071073	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE	May 11, 2007	Substantially Equivalent	Ge Medical Systems Information Technologies
K063690	COLIN PRESS MATE, MODEL BP S510	May 09, 2007	Substantially Equivalent	Omron Healthcare, Inc.
K062194	HYPERVISOR VI CENTRAL MONITORING SYSTEM	Apr 11, 2007	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K070588	PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)	Mar 20, 2007	Substantially Equivalent	Philips Medical Systems
K061379	INFINITY TELESMART TELEMETRY SYSTEM	Feb 16, 2007	Substantially Equivalent	Draeger Medical Systems, Inc.
K063725	MP5 INTELLIVUE PATIENT MONITOR	Feb 08, 2007	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K062098	SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX	Feb 05, 2007	Substantially Equivalent	Datascope Corp.
K062324	MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN	Dec 06, 2006	Substantially Equivalent	GE Healthcare
K062271	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)	Nov 30, 2006	Substantially Equivalent	Philips Medical Systems
K063315	INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90	Nov 20, 2006	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K061993	EQUIVITAL, MODEL EQ-01	Nov 03, 2006	Substantially Equivalent	Hidalgo Limited
K062144	ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810	Oct 12, 2006	Substantially Equivalent	Invivo Corporation
K062576	DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES	Sep 29, 2006	Substantially Equivalent	GE Healthcare
K062095	MCARE 300 VITAL SIGNS MONITOR, MODEL 91220	Sep 29, 2006	Substantially Equivalent	Spacelabs Medical, Inc.
K062283	THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS	Sep 20, 2006	Substantially Equivalent	Philips Medical Systems North America, Inc.
K062392	PHILIPS MP5 INTELLIVUE PATIENT MONITOR	Sep 06, 2006	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K061610	PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS	Aug 14, 2006	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K061675	VISION VXC CENTRAL STATION, MODEL 4300	Aug 02, 2006	Substantially Equivalent	Invivo Corporation
K060833	12SL ECG ANALYSIS PROGRAM	Aug 01, 2006	Substantially Equivalent	Ge Medical Systems Information Technologies
K060281	VS-800 VITAL SIGNS MONITOR	Jun 23, 2006	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K061052	THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90	May 26, 2006	Substantially Equivalent	Philips Medical Systems North America, Inc.
K053207	ARGUS, MODEL LCM	May 19, 2006	Substantially Equivalent	Schiller AG
K061185	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE	May 15, 2006	Substantially Equivalent	GE Healthcare
K060135	MORTARA SURVEYOR TELEMETRY CENTRAL STATION	May 15, 2006	Substantially Equivalent	Mortara Instrument, Inc.
K060223	INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM	Apr 12, 2006	Substantially Equivalent	Draeger Medical Systems, Inc.
K060039	INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS	Apr 12, 2006	Substantially Equivalent	Draeger Medical Systems, Inc.
K053121	TRAM MODULE	Apr 05, 2006	Substantially Equivalent	GE Healthcare
K060541	THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS	Mar 24, 2006	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K053484	INFINITY GAMMA / GAMMAXL, INFINITY VISTA	Feb 22, 2006	Substantially Equivalent	Draeger Medical Systems, Inc.
K060221	THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS	Feb 17, 2006	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K051217	DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)	Feb 03, 2006	Substantially Equivalent	GE Healthcare
K051400	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS	Jan 20, 2006	Substantially Equivalent	GE Healthcare
K053522	PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00	Jan 10, 2006	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K051658	INFINITY ALPHA	Nov 16, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K052801	INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90	Nov 02, 2005	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K052756	DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM	Nov 01, 2005	Substantially Equivalent	GE Healthcare
K052707	M3046B COMPACT PORTABLE PATIENT MONITORS	Oct 20, 2005	Substantially Equivalent	Philips Medical Systems
K051628	INFINITY MONITORS WITH SCIO MODIFICATIONS	Jul 20, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K051367	PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000	Jun 20, 2005	Substantially Equivalent	Ge Medical Systems Information Technologies
K050762	PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90	Apr 22, 2005	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K050742	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00	Apr 05, 2005	Substantially Equivalent	Philips Medical Systems
K043551	DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES	Feb 18, 2005	Substantially Equivalent	Datex-Ohmeda
K043439	INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL	Feb 18, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K042904	INFINITY KAPPA XLT	Feb 18, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K050141	THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS	Feb 11, 2005	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K043549	INFINITY GATEWAY SUITE, VF4	Jan 21, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K043276	DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE	Dec 23, 2004	Substantially Equivalent	Datex-Ohmeda
K042642	AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)	Nov 03, 2004	Substantially Equivalent	Ge Medical Systems Information Technologies
K042656	INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5	Oct 06, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K041772	DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES	Jul 28, 2004	Substantially Equivalent	Datex-Ohmeda
K041790	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE	Jul 23, 2004	Substantially Equivalent	Datex-Ohmeda
K041741	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN	Jul 21, 2004	Substantially Equivalent	Philips Medical Systems, Inc.
K041607	QUINTON Q-TE; RMS	Jul 16, 2004	Substantially Equivalent	Quinton Cardiology, Inc.
K041235	PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS	Jun 04, 2004	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K040458	MODIFICATION TO DASH 3000/4000 PATIENT MONITOR	Jun 03, 2004	Substantially Equivalent	Ge Medical Systems Information Technologies
K033711	FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM	Jun 03, 2004	Substantially Equivalent	Fukuda Denshi USA, Inc.
K040395	CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES	Jun 01, 2004	Substantially Equivalent	Nihon Kohden America, Inc.
K033048	CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS	Jun 01, 2004	Substantially Equivalent	Cas Medical Systems, Inc.
K040246	FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR	May 26, 2004	Substantially Equivalent	Fukuda Denshi USA, Inc.
K033957	INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL	May 14, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K041087	INFINITY GAMMA	May 12, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K040955	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN	May 12, 2004	Substantially Equivalent	Philips Medical Systems, Inc.
K033694	INFINITY MODULAR MONITORS VF4 MODIFICATIONS	Mar 22, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K040357	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II	Mar 03, 2004	Substantially Equivalent	Philips Medical Systems, Inc.
K040304	PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50	Mar 01, 2004	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K030722	ENVOY PATIENT MONITOR	Feb 26, 2004	Substantially Equivalent	Mennen Medical, Inc.
K033964	SOLAR 9500 INFORMATION MONITOR	Jan 15, 2004	Substantially Equivalent	Ge Medical Systems Information Technologies
K033600	INFINITY GAMMAXL	Dec 11, 2003	Substantially Equivalent	Draeger Medical Systems, Inc.
K031124	POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR	Dec 04, 2003	Substantially Equivalent	Datex-Ohmeda, Inc.
K031340	SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO	Nov 25, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K033492	MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM	Nov 24, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K033444	PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER	Nov 21, 2003	Substantially Equivalent	Philips Medical Systems
K033304	MODIFICATION TO DASH 3000/4000 PATIENT MONITOR	Nov 12, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K033365	APEXPRO FH TELEMETRY SYSTEM	Nov 06, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K032290	FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR	Oct 10, 2003	Substantially Equivalent	Fukuda Denshi USA, Inc.
K031760	VIEWPOINT TELEMETRY SYSTEM	Oct 10, 2003	Substantially Equivalent	Datascope Corp.
K031849	SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX	Sep 09, 2003	Substantially Equivalent	Datascope Corp.
K032369	MODIFICATION TO: APEXPRO TELEMETRY SYSTEM	Aug 15, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K031376	DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES	Jul 16, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K031781	DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES	Jun 25, 2003	Substantially Equivalent	Datex-Ohmeda
K030738	SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM	Jun 06, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K031403	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1	May 30, 2003	Substantially Equivalent	Philips Medical Systems, Inc.
K031481	THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20	May 29, 2003	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K030812	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE	May 21, 2003	Substantially Equivalent	Datex-Ohmeda
K022834	DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000	May 13, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K030931	C3 PATIENT MONITOR	May 09, 2003	Substantially Equivalent	Analogic Corp.
K031320	EK-PRO ARRHYTHMIA DETECTION ALGORITHM	May 06, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K030613	VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100	Apr 17, 2003	Substantially Equivalent	Criticare Systems, Inc.
K030657	SIEMENS INFINITY GATEWAY SUITE, MODEL VF2	Mar 21, 2003	Substantially Equivalent	Siemens Medical Solutions
K030575	MODIFICATION TO SOLAR 9500 INFORMATION MONITOR	Mar 21, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K030038	PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR	Mar 12, 2003	Substantially Equivalent	Philips Medical Systems, Inc.
K030105	ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A	Mar 04, 2003	Substantially Equivalent	Nihon Kohden America, Inc.
K030431	MODIFICATION TO DASH 3000/4000 PATIENT MONITOR	Feb 26, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K030313	SIEMENS INFINITY SC 6002XL MODIFICATIONS	Feb 11, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K024108	SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM	Dec 18, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K023871	M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY	Dec 04, 2002	Substantially Equivalent	Philips Medical Systems
K023674	PHILIPS DRUG CALCULATOR SOFTWARE	Nov 29, 2002	Substantially Equivalent	Philips Medical Systems
K023698	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O	Nov 19, 2002	Substantially Equivalent	Philips Medical Systems
K023569	SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS	Nov 04, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K023475	CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES	Oct 24, 2002	Substantially Equivalent	Nihon Kohden America, Inc.
K022485	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE	Oct 03, 2002	Substantially Equivalent	Datex-Ohmeda
K022889	SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER	Sep 25, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K020290	DASH 3000/4000 PATIENT MONITOR	Aug 14, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K021279	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE	Jul 19, 2002	Substantially Equivalent	Datex-Ohmeda
K021422	PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02	May 15, 2002	Substantially Equivalent	Philips Medical Systems
K021325	MODIFICATION OF APEXPRO TELEMETRY SYSTEM	May 07, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K012226	MONITORING SYSTEM,MODEL ARGUS PB-1000	Apr 08, 2002	Substantially Equivalent	Schiller AG
K012915	DINAMAP PRO 1000 MONITOR, MODEL 1000	Mar 21, 2002	Substantially Equivalent	Ge Medical Systems Information Technologies
K020531	PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B	Mar 20, 2002	Substantially Equivalent	Philips Medical Systems
K014261	ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0	Feb 12, 2002	Substantially Equivalent	Philips Medical Systems, Inc.
K011540	VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07	Feb 06, 2002	Substantially Equivalent	Datascope Corp.
K010923	KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E	Jan 23, 2002	Substantially Equivalent	Siemens Elema AB
K014213	SIEMENS INFINITY GATEWAY SUITE	Jan 17, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K013311	MODIFICATION TO: POCKETVIEW ECG SOFTWARE	Jan 03, 2002	Substantially Equivalent	Micromedical Industries, Ltd.
K013624	MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I	Dec 03, 2001	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K013427	MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A	Nov 29, 2001	Substantially Equivalent	Philips Medical Systems, Inc.
K013199	PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B	Nov 28, 2001	Substantially Equivalent	Philips Medical Systems, Inc.
K011918	NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES	Sep 12, 2001	Substantially Equivalent	Nihon Kohden America, Inc.
K012016	INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II	Jul 20, 2001	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K011000	TRAM 2001 MODULE	Jun 29, 2001	Substantially Equivalent	General Electric Medical Systems Information Techn
K011093	AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154	May 01, 2001	Substantially Equivalent	Agilent Technologies, Inc.
K003248	SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER	Dec 21, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K003243	SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL	Dec 21, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K003621	ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0	Dec 20, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K001433	CNS-9300 SERIES CENTRAL STATION	Nov 07, 2000	Substantially Equivalent	Nihon Kohden America, Inc.
K001693	LIFE SCOPE P, MODEL BSM-4100 SERIES	Oct 24, 2000	Substantially Equivalent	Nihon Kohden America, Inc.
K002478	S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08	Oct 05, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K002158	S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE	Sep 06, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K000517	LIFE SCOPE EC, MODEL BSM-1102	Aug 31, 2000	Substantially Equivalent	Nihon Kohden America, Inc.
K002209	GE MARQUETTE ECG ANALYSIS PROGRAM	Aug 18, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K001268	GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS	Jul 17, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K001722	AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE	Jun 30, 2000	Substantially Equivalent	Agilent Technologies Deutschland GmbH
K001664	COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120	Jun 30, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K000815	AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)	Jun 08, 2000	Substantially Equivalent	Datex-Ohmeda
K000882	DATEX-OHMEDA CS/3 TELEMETRY SYSTEM	Jun 05, 2000	Substantially Equivalent	Datex-Ohmeda
K001348	ST/AR ST AND ARRHYTHMIA SOFTWARE	May 17, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K000563	MODIFICATION TO ENVOY PATIENT MONITOR	May 17, 2000	Substantially Equivalent	Mennen Medical , Ltd.
K993608	DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)	Apr 13, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K000168	CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)	Apr 13, 2000	Substantially Equivalent	Datex-Ohmeda
K000854	VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER	Apr 10, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K993974	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	Feb 22, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K992273	HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B	Jan 28, 2000	Substantially Equivalent	Hewlett-Packard GmbH
K992595	HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH	Dec 08, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K992929	DASH 3000 PATIENT MONITOR	Nov 26, 1999	Substantially Equivalent	General Electric Medical Systems Information Techn
K992674	HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A	Nov 08, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K990476	HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION	Jul 22, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K990068	SOLAR 9500 INFORMATION MONITOR	Jul 14, 1999	Substantially Equivalent	General Electric Medical Systems Information Techn
K983996	SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM	Jun 03, 1999	Substantially Equivalent	Spacelabs Medical, Inc.
K990563	SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION	Mar 19, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K982091	CS/3 COMPACT AIRWAY MODULE, M-COVX	Dec 22, 1998	Substantially Equivalent	Datex-Engstrom, Inc.
K982279	VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200	Sep 25, 1998	Substantially Equivalent	Bci Intl., Inc.
K980619	SABRATEK PATIENT HOME MANAGEMENT SYSTEM	Aug 20, 1998	Substantially Equivalent	Sabratek Corp.
K980411	NPB3900 SERIES PATIENT MONITORS	Aug 20, 1998	Substantially Equivalent	Analogic Corp.
K981576	MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A	Jul 17, 1998	Substantially Equivalent	Hewlett-Packard GmbH
K973474	WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS	Mar 13, 1998	Substantially Equivalent	Witt Biomedical Corporation
K971840	OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM	Mar 04, 1998	Substantially Equivalent	Invivo Research, Inc.
K970445	VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300	Jan 30, 1998	Substantially Equivalent	Pace Tech Medical Monitors, Inc.
K972535	MAGLIFE C	Jan 13, 1998	Substantially Equivalent	Odam
K970182	DINAMAP COMPACT MONITOR	Aug 18, 1997	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K922668	PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM	Jan 29, 1997	Substantially Equivalent	Colin Medical Instruments Corp.
K962424	NPB-4000	Dec 20, 1996	Substantially Equivalent	Analogic Corp.
K950264	MAGLIFE	Sep 27, 1996	Substantially Equivalent	Odam
K950436	WITT BIOMEDICAL SERIES IV	Nov 02, 1995	Substantially Equivalent	Witt Biomedical Corporation
K945099	PARAMETERS MONITORES	Jul 13, 1995	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K944860	SCHOLAR PATIENT MONITOR	Jun 20, 1995	Substantially Equivalent	Criticare Systems, Inc.
K944495	MODEL 3200 VASCULAR MINI-LAB	Jun 02, 1995	Substantially Equivalent	Parks Medical Electronics, Inc.
K950536	PICIS CHART+	May 17, 1995	Substantially Equivalent	Picis
K942700	DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340	Mar 01, 1995	Substantially Equivalent	Critikon Company, LLC
K945385	VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300	Jan 31, 1995	Substantially Equivalent	Pace Tech, Inc.
K945134	PORTABLE PATIENT MONITOR	Oct 28, 1994	Substantially Equivalent	Hewlett-Packard Co.
K933624	VITALMAX 4000	Jul 19, 1994	Substantially Equivalent	Pace Tech, Inc.
K922210	HEWLETT-PACKARD MODEL 78730 CAREVUE 5000	Apr 01, 1993	Substantially Equivalent	Hewlett-Packard Co.
K924575	ATLANTIS GUI	Mar 04, 1993	Substantially Equivalent	Hospitronics
K920445	SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES	Mar 02, 1993	Substantially Equivalent	Siemens Medical Electronics
K923054	WITT BIOMEDICAL SERIES II-EP	Feb 25, 1993	Substantially Equivalent	Witt Biomedical Corporation
K922974	PORTABLE PATIENT MONITOR	Dec 07, 1992	Substantially Equivalent	Hewlett-Packard Co.
K922058	MODELS M1175A AND M1176A COMPONENT MONITORING SYST	Oct 06, 1992	Substantially Equivalent	Hewlett-Packard Co.
K921014	MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR	Oct 01, 1992	Substantially Equivalent	Hewlett-Packard Co.
K911646	NGM ESTP MODULE	Feb 21, 1992	Substantially Equivalent	Datex Division Instrumentarium Corp.
K912835	MINI-PACK 911 SERIES	Feb 03, 1992	Substantially Equivalent	Pace Tech, Inc.
K914838	PROPAQ 102,104,106,102EL,104EL,&106EL	Jan 10, 1992	Substantially Equivalent	Protocol Systems, Inc.
K912188	DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700	Dec 04, 1991	Substantially Equivalent	Critikon Company, LLC
K913263	VITALMAX 830 SERIES	Oct 10, 1991	Substantially Equivalent	Pace Tech, Inc.
K912627	MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM	Sep 10, 1991	Substantially Equivalent	Ppg Industries, Inc.
K911051	MONARCH SYSTEM	Aug 22, 1991	Substantially Equivalent	Baxter Healthcare Corp
K881643	BATTERY PACKS FOR CARDIOVASCULAR UNITS	May 17, 1988	Substantially Equivalent	Dowit Service Co., Inc.
K872476	REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION	Sep 21, 1987	Substantially Equivalent	Energy Concepts, Inc.