Product Code: DSI FDA class 2 21 CFR 870.1025

Detector And Alarm, Arrhythmia

Cardiovascular

The Arrhythmia Detector and Alarm is a cardiovascular monitoring device that continuously analyzes the cardiac rhythm, identifies abnormal patterns indicative of arrhythmias, and alerts clinical staff through audible or visual alarms when a dangerous rhythm is detected. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSI and it is regulated under 21 CFR 870.1025 within the Cardiovascular medical specialty.

View on FDA

510(k)s

398

FEI Numbers

121

Registration Numbers

121

Unique Applicants

143

Years Active

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Basic Information

Product Code: DSI
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 398 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243349	BodyGuardian Remote Monitoring System (BGRMS v3.0)	Jan 23, 2026	Substantially Equivalent	Boston Scientific Cardiac Diagnostic Technologies, Inc.
K250356	MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)	Jul 29, 2025	Substantially Equivalent	Infobionic, Inc.
K240177	Zio AT® device (A100A1001)	Oct 30, 2024	Substantially Equivalent	iRhythm Technologies, Inc.
K230265	MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System	Oct 06, 2023	Substantially Equivalent	Infobionic, Inc.
K231276	SmartCardia 7L Platform	Aug 30, 2023	Substantially Equivalent	Smartcardia SA
K193104	Unified Arrhythmia Diagnostic System PocketECG IV	Apr 09, 2020	Substantially Equivalent	Medicalgorithmics S.A.
K192732	BodyGuardian Remote Monitoring System	Mar 26, 2020	Substantially Equivalent	Preventice Technologies, Inc.
K190574	Patient Assistant Model PA97000	Sep 24, 2019	Substantially Equivalent	Medtronic, Inc.
K182532	Liba3 System	May 15, 2019	Substantially Equivalent	National Cardiac, Inc.
K181658	MobileECG 2 BT	Mar 26, 2019	Substantially Equivalent	Memtec Corporation
K173969	Medicalgorithmics Unified Cardiac Rehabilitation System	Jul 11, 2018	Substantially Equivalent	Medicalgorithmics S.A.
K173170	Epicardia Anywhere	Jan 10, 2018	Substantially Equivalent	Medicomp, Inc.
K153473	Braemar Telemetry Patch System	Jul 22, 2016	Substantially Equivalent	Braemar Manufacturing, LLC
K153477	EMMa Electronic Monitoring Management	May 25, 2016	Substantially Equivalent	Vitasystems GmbH
K152701	Matrix Mini ECG Monitor	Apr 22, 2016	Substantially Equivalent	Global Instrumentation, LLC
K152305	Nihon Kohden Afib Detection Program QP-039P	Apr 08, 2016	Substantially Equivalent	Nihon Kohden Corporation
K151835	Vital Signs Patch System	Feb 05, 2016	Substantially Equivalent	Lifewatch Technologies , Ltd.
K151269	ECG Mini System Continuous ECG Monitor and Arrhythmia Detector	Jan 15, 2016	Substantially Equivalent	Lifewatch Technologies , Ltd.
K152491	MoMe Software Platform	Dec 17, 2015	Substantially Equivalent	Infobionic, Inc.
K152550	MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM	Oct 08, 2015	Substantially Equivalent	Medicalgorithmics S.A.
K151188	BodyGuardian Remote Monitoring System	Sep 17, 2015	Substantially Equivalent	Preventice
K143359	CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector	Sep 11, 2015	Substantially Equivalent	Lifewatch Technologies , Ltd.
K151681	IntelliVue Patient Monitor	Jul 17, 2015	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K150117	Medtronic Patient Asistant	May 27, 2015	Substantially Equivalent	Medtronic, Inc.
K150310	IntelliVue Patient Monitor	May 13, 2015	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K142352	CardiacLinx	Mar 12, 2015	Substantially Equivalent	Ross Medical Technology, Inc.
K141441	MENNTOR X7	Jan 09, 2015	Substantially Equivalent	Mennen Medical , Ltd.
K132407	VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)	Dec 19, 2014	Substantially Equivalent	Lifewatch Technologies , Ltd.
K142180	TELESENSE	Dec 12, 2014	Substantially Equivalent	Scottcare Corporation
K140548	CORCAM HEART MONITOR	May 23, 2014	Substantially Equivalent	Corcam Technologia, SA
K131000	V-PATCH SYSTEM	Jan 08, 2014	Substantially Equivalent	Intelesens Limited
K124060	MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM	Feb 21, 2013	Substantially Equivalent	Medicalgorithmics S.A.
K121197	BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT	Aug 10, 2012	Substantially Equivalent	Preventice, Inc.
K112921	MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM	May 16, 2012	Substantially Equivalent	Medicalgorithmics S.A.
K120774	ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT	Apr 10, 2012	Substantially Equivalent	Welch Allyn, Inc.
K113125	INTELLIVUE MX40 PATIENT MONITOR	Nov 17, 2011	Substantially Equivalent	Philips Medical Systems
K111160	INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)	Aug 01, 2011	Substantially Equivalent	Intricon Datrix Corporation
K102507	AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR	Jun 13, 2011	Substantially Equivalent	Tz Medical, Inc.
K103764	REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528	May 04, 2011	Substantially Equivalent	Medtronic, Inc.
K110499	CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR	Apr 06, 2011	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K103142	SPACELABS MULTI-PARAMETER MODULE	Mar 03, 2011	Substantially Equivalent	Spacelabs Healthcare, Inc.
K102111	MEDICAL MAGNETIC TAPE RECORDER	Dec 07, 2010	Substantially Equivalent	Wpr Medical AS
K101703	MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084	Jul 13, 2010	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K101639	CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR	Jun 25, 2010	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K093766	VITALOGIK 6000/6500	May 07, 2010	Substantially Equivalent	Mennen Medical , Ltd.
K100155	TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM	Apr 20, 2010	Substantially Equivalent	Biomedical Systems Corp.
K092947	TELESENTRY, MODEL TS01	Feb 26, 2010	Substantially Equivalent	Scottcare Corporation
K091927	INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90	Nov 03, 2009	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K091971	AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM	Aug 27, 2009	Substantially Equivalent	Corventis, Inc.
K090037	MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG	May 22, 2009	Substantially Equivalent	Medicalgorithmics SP Z.O.O.
K090834	EPICARDIA 5000	May 15, 2009	Substantially Equivalent	Medicomp, Inc.
K083287	AVIVO MOBILE PATIENT MANAGEMENT SYSTEM	Feb 03, 2009	Substantially Equivalent	Corventis, Inc.
K083517	INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90	Jan 16, 2009	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K082475	REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528	Nov 07, 2008	Substantially Equivalent	Medtronic, Inc.
K082633	INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90	Oct 03, 2008	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K081444	BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM	Jul 31, 2008	Substantially Equivalent	Braemar, Inc.
K081257	CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR	May 29, 2008	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K071889	DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE	May 19, 2008	Substantially Equivalent	GE Healthcare
K071995	CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR	Dec 18, 2007	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K073140	VITALOGIK MODEL 4000/4500	Nov 21, 2007	Substantially Equivalent	Mennen Medical , Ltd.
K071655	REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538	Nov 21, 2007	Substantially Equivalent	Medtronic, Inc.
K071641	REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)	Nov 21, 2007	Substantially Equivalent	Medtronic, Inc.
K071805	NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX	Sep 25, 2007	Substantially Equivalent	Datascope Corp.
K062976	MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER	Mar 16, 2007	Substantially Equivalent	Ge Medical Systems Information Technologies
K070260	STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0	Feb 23, 2007	Substantially Equivalent	Philips Medical Systems
K053263	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003	Apr 25, 2006	Substantially Equivalent	Cardionet, Inc.
K052288	VITALOGIK	Dec 20, 2005	Substantially Equivalent	Mennen Medical , Ltd.
K052160	ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)	Dec 16, 2005	Substantially Equivalent	Welch Allyn, Inc.
K050919	LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P	Jun 14, 2005	Substantially Equivalent	Analogic Corp.
K050605	SPACELABS MEDICAL MULTIPARAMETER MODULE 91496	May 03, 2005	Substantially Equivalent	Spacelabs Medical, Inc.
K050175	SPACELABS MEDICAL MULTIPARAMETER MODULE 91496	Mar 04, 2005	Substantially Equivalent	Spacelabs Medical, Inc.
K024213	SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655	Mar 23, 2004	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K033305	INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM	Oct 31, 2003	Substantially Equivalent	Draeger Medical Systems, Inc.
K032858	THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.	Oct 10, 2003	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K031433	SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS	Aug 19, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K032370	CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION	Aug 13, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K023798	MODIFICATION TO ENVOY PATIENT MONITOR	Dec 03, 2002	Substantially Equivalent	Mennen Medical , Ltd.
K020550	PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX	Aug 28, 2002	Substantially Equivalent	Datascope Corp.
K022453	MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM	Aug 21, 2002	Substantially Equivalent	Welch Allyn Protocol, Inc.
K013046	COSMOS SYSTEM	Aug 21, 2002	Substantially Equivalent	Spacelabs Medical, Inc.
K021376	DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE	Jul 24, 2002	Substantially Equivalent	Datex-Ohmeda
K021097	QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52	Jun 28, 2002	Substantially Equivalent	Spacelabs Medical, Inc.
K021300	MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B	May 08, 2002	Substantially Equivalent	Philips Medical Systems
K021251	ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.	May 07, 2002	Substantially Equivalent	Philips Medical Systems
K012467	SOLAR 8000M SYSTEM	Feb 11, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K002604	CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM	Feb 07, 2002	Substantially Equivalent	Invivo Research, Inc.
K020084	FUKUDA DENSHI DYNASCOPE MODEL DS-5700	Feb 06, 2002	Substantially Equivalent	Fukuda Denshi USA, Inc.
K012241	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001	Feb 01, 2002	Substantially Equivalent	Cardionet, Inc.
K014159	PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR	Jan 18, 2002	Substantially Equivalent	Philips Medical Systems, Inc.
K012336	MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500	Oct 03, 2001	Substantially Equivalent	Medical Data Electronics
K011339	QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14	Aug 20, 2001	Substantially Equivalent	Spacelabs Burdick, Inc.
K012461	SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER	Aug 17, 2001	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K011784	MODIFICATION TO ENVOY PATIENT MONITOR	Aug 16, 2001	Substantially Equivalent	Mennen Medical , Ltd.
K011824	AGILENT M2636B TELEMON B MONITOR (TELEMON B)	Jul 02, 2001	Substantially Equivalent	Agilent Technologies, Inc.
K001120	ENVOY PATIENT MONITOR	May 08, 2001	Substantially Equivalent	Mennen Medical , Ltd.
K002758	AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A	Feb 22, 2001	Substantially Equivalent	Agilent Technologies Deutschland GmbH
K002068	ORG-9200A	Feb 08, 2001	Substantially Equivalent	Nihon Kohden America, Inc.
K003576	Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503	Jan 25, 2001	Substantially Equivalent	Quinton, Inc.
K003246	SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION	Dec 21, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K003179	SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM	Nov 09, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K001359	DASH 3000/4000 PATIENT MONITOR	Jul 18, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K001436	AGILENT M2636A TELEMON MONITOR	Jun 07, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K000779	APEXPRO TELEMETRY SYSTEM	May 18, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K001333	AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI	May 17, 2000	Substantially Equivalent	Agilent Technologies Deutschland GmbH
K001057	AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR	May 03, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K000746	FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX	Apr 07, 2000	Substantially Equivalent	Fukuda Denshi USA, Inc.
K000822	AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR	Apr 06, 2000	Substantially Equivalent	Agilent Technologies, GmbH
K993757	SOLAR 7/8000	Mar 23, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K992908	Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)	Mar 06, 2000	Substantially Equivalent	Quinton, Inc.
K993383	HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B	Feb 03, 2000	Substantially Equivalent	Hewlett-Packard GmbH
K993531	PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX	Jan 13, 2000	Substantially Equivalent	Datascope Corp.
K993516	HP M2600A VIRIDIA TELEMETRY SYSTEM	Nov 08, 1999	Substantially Equivalent	Hewlett-Packard Co.
K992637	MUSE CARDIOVASCULAR INFORMATION SYSTEM	Nov 03, 1999	Substantially Equivalent	General Electric Medical Systems Information Techn
K993171	HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A	Oct 21, 1999	Substantially Equivalent	Hewlett-Packard Co.
K991773	HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P	Jun 07, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K990093	ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW	May 11, 1999	Substantially Equivalent	Agilent Technologies
K990972	HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T	Apr 19, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K984089	ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW	Feb 16, 1999	Substantially Equivalent	Zymed Medical Instrumentation
K990125	HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K	Jan 29, 1999	Substantially Equivalent	Hewlett-Packard GmbH
K981376	HEWLETT-PACKARD M1205A VIRIDIA 24 CT	Jan 04, 1999	Substantially Equivalent	Hewlett-Packard Co.
K983980	SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS	Nov 16, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K980045	CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM	Nov 16, 1998	Substantially Equivalent	Invivo Research, Inc.
K983632	SIEMENS SC 8000 BEDSIDE MONITOR	Nov 06, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K980186	ZYMED TELEMETRY SYSTEM	Oct 07, 1998	Substantially Equivalent	Agilent Technologies
K980429	HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)	Sep 09, 1998	Substantially Equivalent	Hewlett-Packard Co.
K982730	SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR	Aug 24, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K982697	MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR	Aug 12, 1998	Substantially Equivalent	Mennen Medical, Inc.
K974698	SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS	Jul 08, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K980728	FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM	Jun 19, 1998	Substantially Equivalent	Fukuda Denshi USA, Inc.
K980882	SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR	Jun 05, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K974792	CS/3(TM) MONITORS*	Jun 02, 1998	Substantially Equivalent	Datex-Engstrom, Inc.
K972502	SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496	May 28, 1998	Substantially Equivalent	Spacelabs Medical, Inc.
K980625	SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)	May 19, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K974747	CS/3 ARRHYTHMIA WORKSTATION	Apr 23, 1998	Substantially Equivalent	Datex-Engstrom, Inc.
K974510	ENVOY PATIENT MONITOR	Apr 14, 1998	Substantially Equivalent	Mennen Medical, Inc.
K971910	MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)	Mar 23, 1998	Substantially Equivalent	Hewlett-Packard GmbH
K972498	OBSERVER * CENTRAL STATION	Feb 17, 1998	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K970358	ENSEMBLE CENTRAL STATION MONITOR	Feb 11, 1998	Substantially Equivalent	Mennen Medical, Inc.
K972714	SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM	Oct 17, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K971131	FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR	Oct 03, 1997	Substantially Equivalent	Fukuda Denshi USA, Inc.
K972282	SPACELABS MEDICAL PCIS PATIENT MONITORS	Sep 25, 1997	Substantially Equivalent	Spacelabs Medical, Inc.
K960884	TELE TRENS TM 10	Sep 12, 1997	Substantially Equivalent	Life Sensing Instrument Company, Inc.
K964624	SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM	Sep 11, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K970585	FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR	Sep 09, 1997	Substantially Equivalent	Fukuda Denshi USA, Inc.
K970348	SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER	Aug 15, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K970920	SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM	Jul 29, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K964593	DIASCOPE TRAVELLER PLUS (4053)	Jun 30, 1997	Substantially Equivalent	S & W Medico Teknik A/S
K970012	ESCORT LINK CENTRAL STATION MONITOR	Jun 26, 1997	Substantially Equivalent	Medical Data Electronics
K965062	SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES	Jun 04, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K964832	HEWLETT-PACKARD CENTRALVUE SOFTWARE	May 15, 1997	Substantially Equivalent	Hewlett-Packard Co.
K970545	DASH 1000 PATIENT MONITOR	May 08, 1997	Substantially Equivalent	Marquette Medical Systems, Inc.
K964187	FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR	May 01, 1997	Substantially Equivalent	Fukuda Denshi USA, Inc.
K952912	SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE	Apr 02, 1997	Substantially Equivalent	Spacelabs Medical, Inc.
K962970	SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION	Mar 25, 1997	Substantially Equivalent	Spacelabs Medical, Inc.
K963057	FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER	Mar 21, 1997	Substantially Equivalent	Fukuda Denshi USA, Inc.
K962827	ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)	Feb 24, 1997	Substantially Equivalent	Marquette Electronics, Inc.
K962291	SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM	Jan 29, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K955023	BRENTWOOD PC-ECG	Jan 22, 1997	Substantially Equivalent	Brentwood Medical Products, Inc.
K962404	SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM	Jan 17, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K964122	HP STAR ST AND ARRHHYTHMIA SOFTWARE	Jan 08, 1997	Substantially Equivalent	Hewlett-Packard Co.
K961165	HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A	Oct 10, 1996	Substantially Equivalent	Hewlett-Packard Co.
K960418	EAGLE PATIENT MONITOR	Oct 02, 1996	Substantially Equivalent	Marquette Electronics, Inc.
K961139	EAGLE PATIENT MONITOR MODEL 3000/3100	Aug 09, 1996	Substantially Equivalent	Marquette Electronics, Inc.
K955743	SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM	Jul 08, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K955059	OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER	Jun 07, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K952054	SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)	Jun 07, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K954852	SOLAR 9000 ANESTHESIA INFORMATION MONITOR	May 29, 1996	Substantially Equivalent	Marquette Electronics, Inc.
K952417	QUEST EXERCISE STRESS SYSTEM	May 22, 1996	Substantially Equivalent	Burdick, Inc.
K935732	CARDIO PERFECT ST 2001	Apr 04, 1996	Substantially Equivalent	Cardio Control BV
K945944	NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM	Nov 27, 1995	Substantially Equivalent	Nihon Kohden America, Inc.
K951370	ZYMED TELEMETRY SYSTEM; MODEL T8010	Oct 06, 1995	Substantially Equivalent	Zymed Medical Instrumentation
K951371	1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION	Oct 04, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K950821	HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24	Oct 03, 1995	Substantially Equivalent	Hewlett-Packard Co.
K952885	SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER	Sep 26, 1995	Substantially Equivalent	Spacelabs Medical, Inc.
K945429	SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)	Aug 15, 1995	Substantially Equivalent	Spacelabs Medical, Inc.
K942196	3050 DIASCOPE NT PATIENT MONITOR	Jun 28, 1995	Substantially Equivalent	S & W Medico Teknik A/S
K946306	SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM	Jun 27, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K944422	BSM-8800A BEDSIDE MONITOR	May 24, 1995	Substantially Equivalent	Nihon Kohden America, Inc.
K935877	NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A	May 24, 1995	Substantially Equivalent	Nihon Kohden America, Inc.
K942058	SPACELABS MEDICAL ECG MODULE (MODEL 90492)	May 17, 1995	Substantially Equivalent	Spacelabs Medical, Inc.
K945384	1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED	May 10, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K944350	SC 6000/ SC 6000P/ R50	Apr 10, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K933177	SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS	Apr 10, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K942147	PACIFIC COMMUNICATIONS MODEL 1100	Jan 30, 1995	Substantially Equivalent	Accucore, Inc.
K935846	MODEL ACUITY CENTRAL STATION	Dec 05, 1994	Substantially Equivalent	Protocol Systems, Inc.
K925510	MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING	Oct 27, 1994	Substantially Equivalent	Spacelabs Medical, Inc.
K920790	MARQUETTE EAGLE MONITOR	Apr 19, 1994	Substantially Equivalent	Marquette Electronics, Inc.
K931716	BATTERY PACK 1017LA	Feb 07, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K930095	SPACELABS MEDICAL PATIENT MONITOR	Sep 03, 1993	Substantially Equivalent	Spacelabs Medical, Inc.
K923747	CC ARHYTHMIS MONITORING OPTION	Jul 20, 1993	Substantially Equivalent	Hewlett-Packard Co.
K925411	MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR	Feb 25, 1993	Substantially Equivalent	Accucore, Inc.
K922027	AMBULATORY (HOLTER) RECORDING, MODIFICATION	Feb 17, 1993	Substantially Equivalent	Biosensor Corp.
K920154	BSM-8800A BEDSIDE MONITOR	Dec 18, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K924672	ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)	Dec 15, 1992	Substantially Equivalent	Agilent Technologies
K920743	DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS	Sep 03, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K914092	BSM-2100A CONFIGURED PATIENT MONITOR	May 28, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K913117	ZB-860PA MULTIPARAMETER TRANSMITTER	Apr 29, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K915153	ESCORT-LINK ARRHYTHMIA OPTION 23L	Apr 27, 1992	Substantially Equivalent	Medical Data Electronics
K910929	OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.	Mar 19, 1992	Substantially Equivalent	Ohmeda Medical
K911835	RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM	Feb 14, 1992	Substantially Equivalent	Gs Microsystems
K913576	DATASCOPE MODEL VISA CENTRAL MONITOR	Jan 28, 1992	Substantially Equivalent	Accucore, Inc.
K913339	HORIZON PACEMAKER DETECTION SOFTWARE	Jan 08, 1992	Substantially Equivalent	Mennen Medical, Inc.
K912744	ORG-8200A UNIVERSAL SIGNAL HOUSING	Dec 09, 1991	Substantially Equivalent	Nihon Kohden America, Inc.
K903940	TYPE 9210 S/ECG	Dec 04, 1991	Substantially Equivalent	S & W Medico Teknik
K913451	HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS	Oct 31, 1991	Substantially Equivalent	Hewlett-Packard Co.
K910109	CARDIOSWISS CM-8	Sep 23, 1991	Substantially Equivalent	Care Systems, Inc.
K905506	ACCUCORE TELEMETRY, MODIFICATION	Sep 06, 1991	Substantially Equivalent	S & W Medico Teknik
K910808	Q-SMART HOLTER SYSTEMS	Jul 17, 1991	Substantially Equivalent	Quinton, Inc.
K900385	ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE	Jul 09, 1991	Substantially Equivalent	Parexel Intl. Corp.
K910490	MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A	Apr 26, 1991	Substantially Equivalent	Hewlett-Packard Co.
K900366	ARRHYTHMIA 9215	Apr 26, 1991	Substantially Equivalent	S & W Medico Teknik
K910291	MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION	Apr 22, 1991	Substantially Equivalent	Hewlett-Packard Co.
K903514	FUKUDA DENSHI MODEL LX-3100	Jan 30, 1991	Substantially Equivalent	Fukuda Denshi USA, Inc.
K900720	MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)	Nov 05, 1990	Substantially Equivalent	Mortara Instrument, Inc.
K900607	MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11	Oct 16, 1990	Substantially Equivalent	Cardiodata Corp.
K903704	FUKUDA DENSHI MODEL FCP-2201 MODIFICATION	Sep 07, 1990	Substantially Equivalent	Fukuda Denshi USA, Inc.
K900540	TRAM PATIENT MONITOR	Jul 17, 1990	Substantially Equivalent	Marquette Electronics, Inc.
K900246	CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512	Jul 03, 1990	Substantially Equivalent	Ppg Industries, Inc.
K900319	SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM	Jun 28, 1990	Substantially Equivalent	Siemens Medical Electronics
K897074	MODEL 215M PATIENT SIMULATOR	May 17, 1990	Substantially Equivalent	Dynatech/Nevada, Inc.
K896775	PCI MODEL 2041-B TELEMETRY MONITOR	May 17, 1990	Substantially Equivalent	Accucore, Inc.
K896862	MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM	Apr 18, 1990	Substantially Equivalent	Del Mar Avionics
K895806	ELATEC HOLTER ANALYZER	Apr 04, 1990	Substantially Equivalent	Ela Medical, Inc.
K896967	HTS 820 CARDIAC MONITOR	Mar 19, 1990	Substantially Equivalent	Life Sensing Instrument Company, Inc.
K895547	GRANDCOR/CARDIOLINE ECT STRESS TESTING	Mar 13, 1990	Substantially Equivalent	Grandcor Medical Systems
K896771	EKG, ECG KENZ, ECG 302	Feb 26, 1990	Substantially Equivalent	Cambridge Medical Instruments, Inc.
K894543	MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER	Feb 08, 1990	Substantially Equivalent	Del Mar Avionics
K897063	FUKUDA DENSHI MODEL DS-3300 ETR	Feb 01, 1990	Substantially Equivalent	Fukuda Denshi USA, Inc.
K895266	AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED	Jan 26, 1990	Substantially Equivalent	Biosensor Corp.
K896103	MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR	Jan 18, 1990	Substantially Equivalent	Advanced Medical Products, Inc.
K894628	MODEL DS-3300 DYNASCOPE PATIENT MONITOR	Jan 08, 1990	Substantially Equivalent	Fukuda Denshi USA, Inc.
K895208	ZYMED MODEL 1610	Dec 12, 1989	Substantially Equivalent	Agilent Technologies
K884643	1100 VITAL SIGNS MONITOR	Oct 30, 1989	Substantially Equivalent	Criticare Systems, Inc.
K894858	CARE 5000 SYSTEM	Oct 12, 1989	Substantially Equivalent	Care Systems, Inc.
K894692	BEDSIDE MONITORS, BSM-8301A, BSM-8302A	Oct 02, 1989	Substantially Equivalent	Nihon Kohden America, Inc.
K894460	SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA	Oct 02, 1989	Substantially Equivalent	Siemens Medical Electronics
K894285	DMI PC HOLTER SCANNER	Sep 26, 1989	Substantially Equivalent	Diagnostic Medical Instruments
K882818	SEER	Jun 22, 1989	Substantially Equivalent	Marquette Electronics, Inc.
K890323	MAX-1 (EXERCISE ELECTROCARDIOGRAPH)	Jun 16, 1989	Substantially Equivalent	Marquette Electronics, Inc.
K885256	MEDILOG EXCEL ECG ANALYSIS SYSTEM	May 31, 1989	Substantially Equivalent	Oxford Medical, Inc.
K891148	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	May 11, 1989	Substantially Equivalent	Del Mar Avionics
K890330	MEDILOG 6000-FD REPORT GENERATOR	Apr 20, 1989	Substantially Equivalent	Oxford Medilog, Inc.
K890338	MEDILOG EDITOR	Apr 19, 1989	Substantially Equivalent	Oxford Medilog, Inc.
K885204	HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)	Apr 19, 1989	Substantially Equivalent	Mennen Medical, Inc.
K884524	HTS 220 CARDIAC MONITOR	Apr 10, 1989	Substantially Equivalent	Life Sensing Instrument Company, Inc.
K882206	SUPERMON ARRHYTHMIA MODULE 7270	Apr 05, 1989	Substantially Equivalent	Kontron Instruments, Inc.
K884216	506 NON-INVASIVE VITAL SIGNS MONITOR	Mar 16, 1989	Substantially Equivalent	Criticare Systems, Inc.
K884106	SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL	Mar 06, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K884887	MODEL 499 SSR ANALYSIS SYSTEM	Feb 06, 1989	Substantially Equivalent	Del Mar Avionics
K884539	HOLTER 24-HOUR ECG PLAYBACK, MODEL 150	Jan 17, 1989	Substantially Equivalent	Rmv Medical (Romavat, Inc.)
K883440	E550 ELECTROCARDIOGRAPH	Jan 17, 1989	Substantially Equivalent	Burdick Corp.
K880505	ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301	Dec 27, 1988	Substantially Equivalent	Ppg Industries, Inc.
K884152	CENTURY COLOR TRACE	Dec 15, 1988	Substantially Equivalent	Biomedical Systems, Inc.
K882978	Q4000 OPTION FOR Q4000	Nov 01, 1988	Substantially Equivalent	Quinton, Inc.
K883410	CARDIOMEGA-T	Oct 17, 1988	Substantially Equivalent	Grandcor Medical Systems
K883103	EPICARDIA PC/FC	Sep 22, 1988	Substantially Equivalent	Medicomp, Inc.
K881488	HOLTER SCANNER	Sep 20, 1988	Substantially Equivalent	Cardiodata Corp.
K881905	MODEL MICRO SI AMBULATORY ECG MONITOR	Aug 02, 1988	Substantially Equivalent	Advanced Medical Products, Inc.
K882513	MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR	Jul 12, 1988	Substantially Equivalent	Cardiac Resucitator Corp.
K881273	HORIZON 2000 ARRHYTHMIA MONITORING OPTION	Jul 12, 1988	Substantially Equivalent	Mennen Medical, Inc.
K880664	MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)	Mar 09, 1988	Substantially Equivalent	Mortara Instrument, Inc.
K870816	KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM	Mar 01, 1988	Substantially Equivalent	Kontron Instruments, Inc.
K871572	RHYTHMSCAN	Feb 22, 1988	Substantially Equivalent	Brentwood Instruments, Inc.
K873533	SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE	Jan 29, 1988	Substantially Equivalent	Medical Electronics Laboratories, Inc.
K873874	CARDIOFAX-V ECG-8110A	Jan 07, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K874768	FUKUDA DENSHI MODEL FCP-231	Dec 18, 1987	Substantially Equivalent	Fukuda Denshi USA, Inc.
K873680	MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM	Nov 23, 1987	Substantially Equivalent	Oxford Medilog, Inc.
K872837	EPICARIDA, LE	Nov 04, 1987	Substantially Equivalent	Medicomp, Inc.
K862947	THE EXPERT MODELS RTS 2000 AND RTS 2000H	Nov 04, 1987	Substantially Equivalent	Ocg Technology, Inc.
K871344	PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR	Oct 20, 1987	Substantially Equivalent	Reynolds Medical , Ltd.
K872497	MODEL MR-45 AMBULATORY HOLTER MONITOR	Oct 06, 1987	Substantially Equivalent	Oxford Medilog, Inc.
K872241	LIFESCOPE 12, BSM 8500A PATIENT MONITOR	Sep 30, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K871389	HOLTER ST SYSTEM, MODEL NO. 5000-20	Sep 01, 1987	Substantially Equivalent	Holter Data Services
K871890	CARDIO-MEGA SYSTEM	Jun 12, 1987	Substantially Equivalent	Grandcor Medical Systems
K871251	CIRCAMED FULL DISCLOSURE SYSTEM	May 22, 1987	Substantially Equivalent	Circadian, Inc.
K871025	FUKUDA DENSHI MODEL FCP-15	Mar 24, 1987	Substantially Equivalent	Fukuda Denshi USA, Inc.
K865032	CARDIOFAX-V ECG-834OA	Mar 10, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K865030	CARDIOFAX-V ECG-8240A	Mar 10, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K864401	PLURIMUS CARDIAC EVALUATION SYSTEM	Mar 03, 1987	Substantially Equivalent	Vivix Corp.
K864149	Q-SCAN II AND Q-SCAN III	Dec 10, 1986	Substantially Equivalent	Quinton, Inc.
K863643	EPICARDIA, PC/FD	Dec 05, 1986	Substantially Equivalent	Medicomp, Inc.
K864506	SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1	Nov 25, 1986	Substantially Equivalent	Spacelabs, Inc.
K864505	SPACELABS ARRHYTHMIA NET (TM) LEVEL 2	Nov 24, 1986	Substantially Equivalent	Spacelabs, Inc.
K863724	MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM	Nov 20, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K862316	CASE 12	Nov 20, 1986	Substantially Equivalent	Marquette Electronics, Inc.
K863159	Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR	Oct 06, 1986	Substantially Equivalent	Quinton, Inc.
K862375	CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM	Jul 01, 1986	Substantially Equivalent	Grandcor Medical Systems
K860980	PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III	May 21, 1986	Substantially Equivalent	Spacelabs, Inc.
K861240	BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER	May 02, 1986	Substantially Equivalent	Mountain View Medical
K860950	SCM-400 HOLTER SYSTEM	May 02, 1986	Substantially Equivalent	Fukuda Denshi USA, Inc.
K852250	595 ARRHYTHMIA MONITORING SYSTEM	May 02, 1986	Substantially Equivalent	Burdick Corp.
K860471	DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER	Apr 30, 1986	Substantially Equivalent	Del Mar Avionics
K860470	DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST	Apr 30, 1986	Substantially Equivalent	Del Mar Avionics
K860834	SPACELABS MEDICAL WORKSTATION	Apr 29, 1986	Substantially Equivalent	Spacelabs, Inc.
K860767	MODEL E 600 ELECTROCARDIOGRAPH	Apr 23, 1986	Substantially Equivalent	Kone Instruments, Inc.
K860167	PRODIGY AND PRODIGY PLUS	Mar 31, 1986	Substantially Equivalent	Cardiodata Corp.
K860024	FUKUDA DENSHI CARDIMAX FCP-211	Mar 31, 1986	Substantially Equivalent	Brentwood Instruments, Inc.
K853669	MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL	Mar 31, 1986	Substantially Equivalent	Hewlett-Packard Co.
K860079	MEDILOG 4500 SYSTEM	Feb 26, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K860078	MEDILOG 2500 SYSTEM	Feb 26, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K855094	FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA	Feb 12, 1986	Substantially Equivalent	Fukuda Denshi USA, Inc.
K854115	CUSTO PORT 24-H ECG AMBULATORY RECORDER	Jan 27, 1986	Substantially Equivalent	Versacor, Inc.
K854282	PREVIEW XT	Jan 08, 1986	Substantially Equivalent	Cambridge Medical Instruments, Inc.
K852892	MEDILOG M6	Dec 09, 1985	Substantially Equivalent	Oxford Medilog, Inc.
K852654	CARDIAC COMMUNICATOR 2000	Dec 04, 1985	Substantially Equivalent	Creative Medical, Inc.
K853352	FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR	Nov 14, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K852968	PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM	Nov 14, 1985	Substantially Equivalent	Personal Computers For Medicine, Inc.
K853209	COMPAS 1	Nov 05, 1985	Substantially Equivalent	Cardiac Care Units, Inc.
K853213	FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON	Oct 11, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K851517	CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO	Oct 02, 1985	Substantially Equivalent	Circadian, Inc.
K852514	MODEL 78560A CENTRAL STATION PATIENT INFO SYS	Sep 12, 1985	Substantially Equivalent	Hewlett-Packard Co.
K852270	LIFESCOPE 8 DEC-8108A AND DEC-8204A	Jul 30, 1985	Substantially Equivalent	Nihon Kohden America, Inc.
K851702	MORTARA INSTRUMENT MODEL EL-1	Jul 29, 1985	Substantially Equivalent	Mortara Instrument, Inc.
K852884	MEDILOG M1	Jul 26, 1985	Substantially Equivalent	Oxford Medilog, Inc.
K852883	MEDILOG M3	Jul 26, 1985	Substantially Equivalent	Oxford Medilog, Inc.
K843731	KENZ 80Z MARK II	Jul 11, 1985	Substantially Equivalent	Suzuken Co., Ltd.
K852207	OXFORD VDT-40 DISPLAY TERMINAL	Jun 11, 1985	Substantially Equivalent	Oxford Medilog, Inc.
K850897	FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES	Apr 10, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K844791	SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A	Apr 10, 1985	Substantially Equivalent	Analogic Corp.
K844464	PROGRAMMABLE PATIENT SIMULATOR	Apr 03, 1985	Substantially Equivalent	Ramford Labs
K842976	BRENTWOOD EZ SCAN 200 AMBULATORY ECG	Mar 01, 1985	Substantially Equivalent	Brentwood Instruments, Inc.
K841083	QUIKPAGE ARRHYTHMIA REPORT GENERATOR	Feb 07, 1985	Substantially Equivalent	Agilent Technologies
K850136	CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM	Feb 01, 1985	Substantially Equivalent	Cardio Data
K841084	ARRHYTHMIA SYSTEM AC-11	Feb 01, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K823844	HORIZON ECG SYSTEM	Jan 10, 1985	Substantially Equivalent	Beckman Instruments, Inc.
K840899	SERVOMED ARRHYCOMP CENTRAL MONITOR SYS	Nov 20, 1984	Substantially Equivalent	Litton Medical Electronics
K842715	DOCUMENTOR	Nov 19, 1984	Substantially Equivalent	Life Technology
K842123	PERSONAL CL SINGLE-CHANNEL ELECTROCAR	Nov 16, 1984	Substantially Equivalent	Parexel Intl. Corp.
K843503	AEGIS AMBULATORY MONITORING SYSTEM	Oct 26, 1984	Substantially Equivalent	Aegis Medical Systems, Inc.
K843513	EPICARDIA, PC	Oct 22, 1984	Substantially Equivalent	Medicomp, Inc.
K843287	ARRHYTHMIA CENTRAL OCC-7101	Oct 18, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K842616	SPACELABS ALPHA PC PATIENT COMPUTER	Oct 18, 1984	Substantially Equivalent	Spacelabs, Inc.
K841416	PEDIATRIC DIAG. CRITERIA OPTION 5600C	Oct 18, 1984	Substantially Equivalent	Hewlett-Packard Co.
K842640	SPACELABS ICR ARRHYTHMIA MASTER I HOLTER	Oct 04, 1984	Substantially Equivalent	Spacelabs, Inc.
K841500	LIFESCOPE 6 OEC-6201	Aug 28, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K841172	MONITOR ONE	Jul 27, 1984	Substantially Equivalent	Qmed, Inc.
K840622	CARDIO EXPRESS 100 HOLTER SCANNER	Jul 02, 1984	Substantially Equivalent	Del Mar Avionics
K834211	LEAP FROG	Jun 05, 1984	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K834597	ALPHA MASS STORAGE CARDULE 1895	Apr 17, 1984	Substantially Equivalent	Spacelabs, Inc.
K834397	HOLTER CARDIOGRAPHY SYS 6201	Apr 17, 1984	Substantially Equivalent	Instruments For Cardiac Research
K832354	HOLTA-MED INFORMER PLAYBACK	Jan 27, 1984	Substantially Equivalent	Holta-Med
K833162	AMBULATORY MONITORING DEVICE	Jan 10, 1984	Substantially Equivalent	Oxford Medilog, Inc.
K831676	BIOSENSOR ASC SYSTEM	Dec 01, 1983	Substantially Equivalent	Biosensor Corp.
K831638	SINGLE BED ARRHYTHMIA MONITOR AM500	Nov 14, 1983	Substantially Equivalent	Lifeline Systems, Inc.
K832693	ARRHYTHMIA III CARDULE #1919	Nov 07, 1983	Substantially Equivalent	Spacelabs, Inc.
K832772	SATURN-24HR. HOLTER SCANNER	Nov 03, 1983	Substantially Equivalent	Hittman Medical Systems
K831274	WLECTROCARDIOGRAPH ECG-7204	Oct 27, 1983	Substantially Equivalent	Nihon Kohden America, Inc.
K830830	CIRCA MED TWO-CHANNEL	Jun 18, 1983	Substantially Equivalent	Circadian, Inc.
K823586	COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200	Apr 06, 1983	Substantially Equivalent	Brentwood Instruments, Inc.
K823585	COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13	Apr 06, 1983	Substantially Equivalent	Brentwood Instruments, Inc.
K830029	SIRECUST 400	Mar 31, 1983	Substantially Equivalent	Analogic Corp.
K830407	ECLIPSE	Mar 24, 1983	Substantially Equivalent	Diagnostic Medical Instruments
K830306	HEARTRATE PLUS ECG CARDULE #1918	Mar 17, 1983	Substantially Equivalent	Spacelabs, Inc.
K830013	EPI CARDIA SYS. - AMBULATORY MONITOR	Feb 28, 1983	Substantially Equivalent	Medicomp, Inc.
K830163	IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS	Feb 18, 1983	Substantially Equivalent	Intl. Business Machines
K822968	ELECTROCARDIOGRAPH INTERPRETER	Dec 15, 1982	Substantially Equivalent	Suzuken Co., Ltd.
K822616	LS6 ARRYTHMIA DISCRIMINATOR	Oct 18, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K822718	SERIES 7000 BEDSIDE PATIENT MONITOR	Oct 04, 1982	Substantially Equivalent	Marquette Electronics, Inc.
K821711	CARDIO TEHCHANALYZER	Oct 04, 1982	Substantially Equivalent	Cardio Technology , Ltd.
K822030	MULTIPLE LEAD ARRHYTHMIA MODULE	Sep 28, 1982	Substantially Equivalent	Marquette Electronics, Inc.
K820881	MEMOPORT C	May 18, 1982	Substantially Equivalent	Litton Medical Electronics
K820856	EVENTMASTER 2	Apr 29, 1982	Substantially Equivalent	Instruments For Cardiac Research
K820438	QUINTON Q2000 ETT MONITORING SYSTEM	Apr 29, 1982	Substantially Equivalent	Quinton, Inc.
K820477	ALGORITHM OF THE ARRHYTHMIA MON. SYS	Apr 15, 1982	Substantially Equivalent	Hewlett-Packard Co.
K812914	MICRO-PREPROCESSOR UNIT	Dec 29, 1981	Substantially Equivalent	General Electric Co.
K813287	CC-201 ECG MONITORING SYSTEMS	Dec 14, 1981	Substantially Equivalent	Anthro-Metrics Corp.
K812149	CARDIO-DATA SYSTEM, #MARK III	Aug 31, 1981	Substantially Equivalent	Cardio Data
K811581	ARRHYTHMIA FUNCTION BLOCK	Aug 13, 1981	Substantially Equivalent	Honeywell, Inc.
K810940	THE BETA	Jul 16, 1981	Substantially Equivalent	Burdick Corp.
K811792	ARRYTHMIA PRINTER OPTION	Jul 10, 1981	Substantially Equivalent	American Edwards Laboratories
K811527	CC-103	Jun 16, 1981	Substantially Equivalent	Anthro-Metrics Corp.
K811122	DEL MAR AVIONICS MODELS 9400 & 9401	Jun 12, 1981	Substantially Equivalent	Del Mar Avionics
K803208	SIRECUST 358	May 27, 1981	Substantially Equivalent	Siemens Corp.
K810027	DATAMEDIX PECGASYS SYSTEM	Mar 26, 1981	Substantially Equivalent	Datamedix
K802900	HEART SENTINEL	Mar 11, 1981	Substantially Equivalent	Totemite Medical Electronics
K801903	SERIES 4000 STRESS & EXERCISE SYSTEM	Mar 11, 1981	Substantially Equivalent	Instruments For Cardiac Research
K803282	GUARDIAN MONITOR (CARDIOVASCULAR)	Feb 27, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802312	CC101 ECG MONITORING SYSTEM	Jan 07, 1981	Substantially Equivalent	Anthro-Metrics Corp.
K802472	BIOMETRIC ERG SYSTEM	Nov 26, 1980	Substantially Equivalent	Biometric Analysis Group, Inc.
K802272	COMPUTER ECG TERMINAL	Sep 26, 1980	Substantially Equivalent	Compumed, Inc.
K802103	ECG RECALL & EDIT PRODUCT VERSION-A3601	Sep 26, 1980	Substantially Equivalent	General Electric Co.
K802033	OXFORD INTENSIVE CARE PATIENT MON. SYS	Sep 26, 1980	Substantially Equivalent	Oxford Medilog, Inc.
K801831	EVALUATOR #9500 DYNAMIC ELEC/SCANNER	Sep 09, 1980	Substantially Equivalent	Del Mar Avionics
K801762	MICRO-PROCESSOR UNIT #A3600AC	Aug 27, 1980	Substantially Equivalent	General Electric Co.
K792081	SPECTRA CENTRAL PT MONITORING SYS	Nov 13, 1979	Substantially Equivalent	American Optical Corp.
K791632	COMPU-SCAN	Nov 13, 1979	Substantially Equivalent	Hittman Medical Systems
K791487	MODEL 78520A ARRHYTHMIA MONITORING SYS	Aug 28, 1979	Substantially Equivalent	Hewlett-Packard Co.
K791424	DCG-VII ELECTROCARDIOSCANNER	Aug 28, 1979	Substantially Equivalent	Del Mar Avionics
K790837	ARRHYTHMIA II CARDULE	May 16, 1979	Substantially Equivalent	Spacelabs, Inc.
K790287	ANALYZER, MEDILOG II	Feb 28, 1979	Substantially Equivalent	Oxford Medilog, Inc.
K781911	ECG ANALYZER, HIGH SPEED	Nov 30, 1978	Substantially Equivalent	Cardio-Dynamics Laboratories, Inc.
K781845	CAMSCAN SYSTEM	Nov 20, 1978	Substantially Equivalent	American Optical Corp.
K780432	ARRHYTHMIA PROGRAM MODULE	May 26, 1978	Substantially Equivalent	Midwest Analog & Digital, Inc.
K780343	ARRHYTHMIA TREND ENHANCEMENT	Apr 18, 1978	Substantially Equivalent	American Optical Corp.
K772360	ARRHYTHMIA MODULE	Jan 12, 1978	Substantially Equivalent	General Electric Co.
K771374	SCANNER TREND SYSTEM	Aug 04, 1977	Substantially Equivalent	Instruments For Cardiac Research
K760368	MONITORING & STRESS TESTING EQUIPMENT	Feb 28, 1977	Substantially Equivalent	Advanced Medical, Inc.
K760884	MICRO-COMPUTER ARRHYTHONIA SYSTEM	Dec 09, 1976	Substantially Equivalent	Spacelabs, Inc.