Product Code: DSH FDA class 2 21 CFR 870.2800

Recorder, Magnetic Tape, Medical

Cardiovascular

The Medical Magnetic Tape Recorder is a cardiovascular data recording device used to store physiological signals such as ECG or hemodynamic waveforms on magnetic tape for later playback and analysis, such as in ambulatory Holter monitoring. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSH and it is regulated under 21 CFR 870.2800 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

194

FEI Numbers

Registration Numbers

Unique Applicants

121

Years Active

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Basic Information

Product Code: DSH
Device Class: FDA class 2
Regulation Number: 870.2800
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 194 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252389	Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)	Apr 23, 2026	Substantially Equivalent	Smwmed, Inc.
K253293	VitaloJAK Clinic (Model 7100)	Dec 03, 2025	Substantially Equivalent	Vitalograph , Ltd.
K243650	Zio® monitor (DFG0001)	Aug 15, 2025	Substantially Equivalent	iRhythm Technologies, Inc.
K243603	AeviceMD	May 05, 2025	Substantially Equivalent	Aevice Health Pte. , Ltd.
K242583	AT-Patch (ATP-C130/ATP-C70)	May 02, 2025	Substantially Equivalent	Atsens Co., Ltd.
K232670	HiCardi+ H100	Sep 20, 2024	Substantially Equivalent	MEZOO Co., Ltd.
K233906	S-Patch (S-Patch ExL)	Feb 16, 2024	Substantially Equivalent	Wellysis Corp.
K231104	ABPMpro	Nov 27, 2023	Substantially Equivalent	Somnomedics GmbH
K233110	Carnation Ambulatory Monitor	Nov 22, 2023	Substantially Equivalent	Bardy Diagnostics, Inc.
K230184	Holter ECG and ABP System	Sep 25, 2023	Substantially Equivalent	Edan Instruments, Inc.
K231289	S-Patch Ex Wearable ECG Patch	Aug 30, 2023	Substantially Equivalent	Wellysis Corp.
K223382	AeviceMD	Jul 07, 2023	Substantially Equivalent	Aevice Health Pte. , Ltd.
K223049	CardioSTAT® ECG Test Solution	Mar 22, 2023	Substantially Equivalent	Icentia, Inc.
K214073	eWave Monitor	Oct 20, 2022	Substantially Equivalent	Wearlinq, Inc.
K203638	AT-Patch ECG Analysis System	Oct 12, 2022	Substantially Equivalent	Atsens Co., Ltd.
K210179	QOCA Portable ECG Monitoring Device	Aug 02, 2022	Substantially Equivalent	Quanta Computer, Inc.
K220893	Strados Remote Electronic Stethoscope Platform (RESP)	Apr 27, 2022	Substantially Equivalent	Strados Labs, Inc.
K203168	LifeLens Wireless ECG Monitor	Jul 20, 2021	Substantially Equivalent	LifeLens Technologies, Inc.
K202359	Zio Monitor	May 21, 2021	Substantially Equivalent	iRhythm Technologies, Inc.
K201644	QardioCore	Feb 28, 2021	Substantially Equivalent	Qardio, Inc.
K210036	Carnation Ambulatory Monitor (CAM)	Feb 05, 2021	Substantially Equivalent	Bardy Diagnostics, Inc.
K202456	M5 Recorder	Dec 29, 2020	Substantially Equivalent	Global Instrumentation, LLC
K201077	Strados Remote Electronic Stethoscope Platform (RESP)	Dec 20, 2020	Substantially Equivalent	Strados Labs
K201040	Bioflux Software II	Jul 29, 2020	Substantially Equivalent	Biotricity
K200870	Carnation Ambulatory Monitor	May 01, 2020	Substantially Equivalent	Bardy Diagnostics, Inc.
K192556	Carnation Ambulatory Monitor	Oct 17, 2019	Substantially Equivalent	Bardy Diagnostics, Inc.
K191471	Carnation Ambulatory Monitor	Aug 30, 2019	Substantially Equivalent	Bardy Diagnostics, Inc.
K191000	Carnation Ambulatory Monitor	May 16, 2019	Substantially Equivalent	Bardy Diagnostics, Inc.
K173461	ECG recorder and Arrhythmia Detector	Aug 03, 2018	Substantially Equivalent	Smart Solutions Technologies SL
K172862	Portable ECG Monitor (ECG3)	Jul 24, 2018	Substantially Equivalent	Andon Health Co, Ltd.
K171410	ePatch	Jan 04, 2018	Substantially Equivalent	Braemar Manufacturing, LLC
K171936	Peerbridge Cor(TM) System	Sep 27, 2017	Substantially Equivalent	Peerbridge Health, Inc.
K162503	Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software	Mar 24, 2017	Substantially Equivalent	Cardiac Insight, Inc.
K163535	my Patch sl	Feb 22, 2017	Substantially Equivalent	Dms-Service, LLC
K162571	Bioflux Software	Oct 13, 2016	Substantially Equivalent	Biotricity, Inc.
K160704	myPatch-s	Jul 15, 2016	Substantially Equivalent	Dms-Service, LLC
K142468	Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System	Jul 11, 2015	Substantially Equivalent	Cardiac Insight, Inc.
K143513	ZIO SR ECG Monitoring Service	Jun 19, 2015	Substantially Equivalent	iRhythm Technologies, Inc.
K143067	Carnation Ambulatory Monitor	Dec 22, 2014	Substantially Equivalent	Bardy Diagnostics, Inc.
K131190	MYPATCH	Oct 29, 2013	Substantially Equivalent	Dms-Service, LLC
K130288	STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE	May 29, 2013	Substantially Equivalent	Cardiac Insight, Inc.
K121319	ZIO PATCH	Jul 18, 2012	Substantially Equivalent	iRhythm Technologies, Inc.
K113862	ZIO PATCH	Feb 06, 2012	Substantially Equivalent	iRhythm Technologies, Inc.
K113176	MYSENSE HEART	Dec 21, 2011	Substantially Equivalent	Cardiac Science Corporation
K110525	VITALOGRAPH MODEL 7100 - VITALOJAK	Nov 23, 2011	Substantially Equivalent	Vitalograph (Ireland) , Ltd.
K111320	GLOBALCARDIO	Oct 07, 2011	Substantially Equivalent	Cardiocomm Solutions, Inc.
K111745	KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER	Aug 01, 2011	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K111180	VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY	Jun 28, 2011	Substantially Equivalent	Vasomedical, Inc.
K111096	VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY	Jun 24, 2011	Substantially Equivalent	Vasomedical, Inc.
K101022	PULMOTRACK 5050 WHOLTER, MODEL 5050	Jul 09, 2010	Substantially Equivalent	Karmelsonix
K092785	COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301	Apr 02, 2010	Substantially Equivalent	Vasomedical, Inc.
K091505	COR12+	Jun 10, 2009	Substantially Equivalent	Viasys Healthcare GmbH
K090363	ZIO PATCH, MODEL Z100	May 08, 2009	Substantially Equivalent	iRhythm Technologies, Inc.
K083820	VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C	Apr 01, 2009	Substantially Equivalent	Vasomedical, Inc.
K073152	PC-180 / PRINCE 180 EASY ECG MONITOR	Jan 10, 2008	Substantially Equivalent	Shenzhen Creative Industry Co., Ltd.
K070818	MEDILOGAR4, MEDILOGAR12	Apr 06, 2007	Substantially Equivalent	Tom Medical Entwicklungs GmbH
K062007	DMS 300-7	Aug 16, 2006	Substantially Equivalent	Diagnostic Monitoring Software
K050896	H12+ HOLTER RECORDER	Aug 24, 2005	Substantially Equivalent	Mortara Instrument, Inc.
K033037	MODIFICATION TO GLOBALCARDIO	Oct 31, 2003	Substantially Equivalent	Cardiocomm Solutions, Inc.
K032103	PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A	Jul 22, 2003	Substantially Equivalent	Philips Medical Systems
K022540	CARDIO ID+(RZ153+)	Oct 24, 2002	Substantially Equivalent	Rozinn Electronics, Inc.
K022297	GLOBAL ECG MANAGEMENT SYSTEM (GEMS)	Sep 27, 2002	Substantially Equivalent	Cardiocomm Solutions, Inc.
K020825	KING OF HEARTS EXPRESS + AF MONITOR	Apr 05, 2002	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K013354	GLOBALCARDIO	Jan 31, 2002	Substantially Equivalent	Cardiocomm Solutions, Inc.
K004007	DR180+OXY	Jan 25, 2001	Substantially Equivalent	North East Monitoring, Inc.
K001025	LIFECARD CF COMPACT RECORDER	Apr 19, 2000	Substantially Equivalent	Reynolds Medical , Ltd.
K982448	CARDIOLIGHT	Jun 11, 1999	Substantially Equivalent	Capintec, Inc.
K990027	OMNICORDER, MODEL 464	Feb 09, 1999	Substantially Equivalent	Del Mar Avionics
K982384	MERCATOR	Jan 27, 1999	Substantially Equivalent	Harley Street Software , Ltd.
K973735	MICROVIT MT-100	Aug 25, 1998	Substantially Equivalent	Schiller America, Inc.
K974420	M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION	Feb 19, 1998	Substantially Equivalent	Hewlett-Packard Co.
K971670	3 CHANNEL DIGITAL AMBULATORY ECG RECORDER	Jan 29, 1998	Substantially Equivalent	Galix Biomedical Instrumentation, Inc.
K970298	DM-400 HOLTER ECG CASSETTE RECORDER	Aug 20, 1997	Substantially Equivalent	Diagnostic Monitoring
K971604	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP	Jul 28, 1997	Substantially Equivalent	Alexander Mfg. Co.
K970902	MEDILOG FD4	May 05, 1997	Substantially Equivalent	Oxford Instruments Medical Systems
K963174	HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)	Mar 13, 1997	Substantially Equivalent	Del Mar Avionics
K944180	MODEL 700	Mar 07, 1997	Substantially Equivalent	Memtec Corp.
K960925	NORTHEAST MONITORING DR180	Jul 31, 1996	Substantially Equivalent	North East Monitoring, Inc.
K950854	VITALOGRAPH 2110 SOFTWARE INTERFACE	Oct 12, 1995	Substantially Equivalent	Vitalograph , Ltd.
K950020	HOLTER PACERCORDER(R)	Aug 17, 1995	Substantially Equivalent	Del Mar Avionics
K951605	SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM	Jul 14, 1995	Substantially Equivalent	Spacelabs, Inc.
K943862	SONICAID MODEL MR-63 AMBULATORY ECG RECORDER	Jun 07, 1995	Substantially Equivalent	Oxford Instruments Medical Systems
K942653	HOLTER SSR DIGICORDER(TM)	May 10, 1995	Substantially Equivalent	Del Mar Avionics
K945130	BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER	Apr 12, 1995	Substantially Equivalent	Braemar Corp.
K942781	DIGITAL HOLTER RECORDER	Jan 24, 1995	Substantially Equivalent	Agilent Technologies
K942862	HEARTPRINT	Jan 18, 1995	Substantially Equivalent	Medata, Inc.
K943278	TRACKER 2/TRACKER 3 HOLTER RECORDER	Oct 20, 1994	Substantially Equivalent	Reynolds Medical , Ltd.
K942438	ALTAIR 6100 CASSETTE RECORDER	Aug 05, 1994	Substantially Equivalent	Burdick, Inc.
K923664	SCOLE 300 ECG RECORDER	Jan 13, 1994	Substantially Equivalent	Scole Engineering Co.
K934660	R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211	Dec 03, 1993	Substantially Equivalent	R & D Batteries, Inc.
K930894	MULTITRAK-PLUS	Nov 01, 1993	Substantially Equivalent	Zymed Medical Instrumentation
K932929	HRV 4000EM	Sep 09, 1993	Substantially Equivalent	All-Tronics Medical Systems
K920572	UNISCAN 24 ECG ROCORDER	Apr 06, 1992	Substantially Equivalent	Uniscan , Ltd.
K921068	GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300	Mar 30, 1992	Substantially Equivalent	Datrix
K913600	WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM	Oct 16, 1991	Substantially Equivalent	Ralin Laboratories, Inc.
K910884	CARD GUARD, MODELS CG-6000 & CG-7000	Oct 16, 1991	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K913038	SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION	Oct 04, 1991	Substantially Equivalent	Spacelabs, Inc.
K904177	GALIX MA-6C HOLTER CASSETTE RECORDER	Sep 20, 1991	Substantially Equivalent	Galix Instrumentacion Biomedica
K904176	GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER	Sep 20, 1991	Substantially Equivalent	Galix Instrumentacion Biomedica
K911257	MR-5200 FULL DISCLOSURE SYSTEM	Aug 19, 1991	Substantially Equivalent	Mennen Medical, Inc.
K911097	PR4	Aug 07, 1991	Substantially Equivalent	Mortara Instrument, Inc.
K912427	MULTICHANNEL RECORDING SYSTEM	Jul 26, 1991	Substantially Equivalent	Bionique
K902766	ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE	Mar 12, 1991	Substantially Equivalent	Advanced Ischemia Recorders, Inc.
K903331	ROZINN 151	Oct 22, 1990	Substantially Equivalent	Rozinn Electronics, Inc.
K902486	CARDIOVISTA	Aug 23, 1990	Substantially Equivalent	Cardionostics, Inc.
K901251	MODEL 9101 RECORDER/ANALYZER SYSTEM	May 22, 1990	Substantially Equivalent	Aequitron Medical, Inc.
K895793	MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION	Feb 13, 1990	Substantially Equivalent	Del Mar Avionics
K896153	MODIFIED DR-2C/PMC 100	Jan 19, 1990	Substantially Equivalent	General Devices
K895961	MODEL MC6500 ELECTROCARDIOGRAPH	Jan 04, 1990	Substantially Equivalent	Cambridge Medical Instruments, Inc.
K884126	E-RAM	Oct 30, 1989	Substantially Equivalent	Reynolds Medical , Ltd.
K893836	EPLAB (ELECTROCARDIOGRAPHIC MONITOR)	Sep 08, 1989	Substantially Equivalent	Quinton Electrophysiology Corp.
K890114	IMEX RHYTHM TEK	Jul 27, 1989	Substantially Equivalent	Racom, Inc.
K892227	EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)	Jun 20, 1989	Substantially Equivalent	Edentec Corp.
K892067	MT9000 CHART RECORDER	Jun 05, 1989	Substantially Equivalent	Astro-Med, Inc.
K890647	MEDILOG 9000-II AMBULATORY RECORDER	Mar 15, 1989	Substantially Equivalent	Oxford Medilog, Inc.
K884330	MODEL 463 ELECTROCARDIORECORDER RECORDER	Jan 05, 1989	Substantially Equivalent	Del Mar Avionics
K880303	POLYCORD II	Dec 05, 1988	Substantially Equivalent	Technetics, Inc.
K884009	MODEL 459 ELECTROCARDIOCORDER RECORDER	Nov 09, 1988	Substantially Equivalent	Del Mar Avionics
K882366	RHYTHMSCAN HR HOLTER RECORDER	Aug 02, 1988	Substantially Equivalent	Brentwood Instruments, Inc.
K874313	MODEL 492 SSR (TM) RECORDER	Feb 22, 1988	Substantially Equivalent	Del Mar Avionics
K874571	PATIENTWATCH (TM)	Jan 29, 1988	Substantially Equivalent	Advanced Medical Technology, Inc.
K873337	MODEL SSR1 HOLTER MONITOR	Oct 09, 1987	Substantially Equivalent	Cardiodata Corp.
K872508	MODEL MICRO FD+ AMBULATORY ECG MONITOR	Sep 25, 1987	Substantially Equivalent	Advanced Medical Products, Inc.
K871587	THE TELESCAN C.A.R.E. SYSTEM	Aug 12, 1987	Substantially Equivalent	Telescan Medical Systems
K872234	TRANSCOR RADIO-STETHOSCOPE MB	Aug 11, 1987	Substantially Equivalent	Transcor, Inc.
K872229	VITEL III, ECG TRANSMITTER	Jul 29, 1987	Substantially Equivalent	Equimed Corp.
K872246	MODIFIED MODEL 9431 TELETRACE TRANSMITTER	Jul 21, 1987	Substantially Equivalent	Medtronic Vascular
K870578	NIGHTWATCH(TM) SYSTEM	Jun 29, 1987	Substantially Equivalent	Buckman Co., Inc.
K871944	FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)	Jun 24, 1987	Substantially Equivalent	Futurecare Systems, Inc.
K872087	UMSC HOLTER MONITORING KIT	Jun 19, 1987	Substantially Equivalent	United Medical Supply Co., Inc.
K871045	DMI AMBULATORY HOLTER MONITOR	May 19, 1987	Substantially Equivalent	Diagnostic Medical Instruments
K870537	MODEL MICRO ST AMBULATORY ECG MONITOR	Apr 23, 1987	Substantially Equivalent	Advanced Medical Products, Inc.
K870554	CASSETTE TAPE REPLAY SYSTEM	Mar 23, 1987	Substantially Equivalent	Research Instrumentation Associates, Inc.
K863922	VERSAFLEX(TM) DELTA ST(TM) MONITOR	Oct 20, 1986	Substantially Equivalent	Versaflex Delivery Systems, Inc.
K863863	CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)	Oct 15, 1986	Substantially Equivalent	Cardionostics, Inc.
K862526	MINI-HOLTER, MODEL 2000	Aug 25, 1986	Substantially Equivalent	Holter Recorders
K862776	SPECTRUM POLYCORD I RECORDER SYSTEM	Aug 18, 1986	Substantially Equivalent	Cardionics, Inc.
K854269	MODEL 509A PHYSIOCORDER AMBULATORY RECORDER	Apr 11, 1986	Substantially Equivalent	Del Mar Avionics
K860182	MODEL MR-35 HOLTER RECORDER	Feb 26, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K860181	MODEL MR-30 HOLTER RECORDER	Feb 26, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K853985	MVM 4000 HOLTER IV RECORDER	Nov 06, 1985	Substantially Equivalent	Mountain View Medical
K853262	CARDIO DATA PACERECORDER PR3	Oct 11, 1985	Substantially Equivalent	Cardio Data
K851971	SERIES 7000/HOLTER RECORDER	Jun 20, 1985	Substantially Equivalent	Pfizer, Inc.
K842349	AMBULATORY PH RECORDING DEVICE	Jun 14, 1985	Substantially Equivalent	Clinical Data Instruments, Inc.
K844940	SPACELABS MODEL 90201 HOLTER RECORDER	Feb 14, 1985	Substantially Equivalent	Spacelabs, Inc.
K844977	HOLTER CURA-LITE RECORDER	Jan 14, 1985	Substantially Equivalent	Cardionostics, Inc.
K841654	DEL MAR AVIONICS 509 NEUROCORDER AMBUL	Dec 11, 1984	Substantially Equivalent	Del Mar Avionics
K841472	CARDIORHYTHM 2000	Oct 29, 1984	Substantially Equivalent	Biogenix, Inc.
K841868	MINGOGRAF 7	Oct 24, 1984	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K842954	CARDIONOSTICS HOLTER DURA-LITE RECORDE	Sep 04, 1984	Substantially Equivalent	Cardionostics, Inc.
K833349	EVENT TAPE RECORDER 8293	Apr 17, 1984	Substantially Equivalent	Aequitron Medical, Inc.
K833348	RESPIRATION/8100-HEART RATE RECORDER	Apr 17, 1984	Substantially Equivalent	Aequitron Medical, Inc.
K834257	CARDIODATA PACE RECORDER	Jan 30, 1984	Substantially Equivalent	Cardio Data
K833823	HOLTER PERFORMER FEATHER WEIGHT/CASS	Dec 01, 1983	Substantially Equivalent	Applied Cardiac Systems
K833661	ELECTROCARDIOCORDER RECORDER 453	Nov 28, 1983	Substantially Equivalent	Del Mar Avionics
K832395	HOLTA-MED RECORDER	Oct 20, 1983	Substantially Equivalent	Holta-Med
K830907	AMBULATORY ECG EVENT RECORDER	Jul 28, 1983	Substantially Equivalent	Brentwood Instruments, Inc.
K830915	OMAR	Jul 07, 1983	Substantially Equivalent	Oxford Medilog, Inc.
K831262	DATA IV AMBULATORY MONITOR	May 25, 1983	Substantially Equivalent	Cardio-Scan of Texas
K830489	RECORDER DMI	May 25, 1983	Substantially Equivalent	Diagnostic Medical Instruments
K831184	CARDIO DATA PACEMAKER RECORDER	May 09, 1983	Substantially Equivalent	Cardio Data
K830519	CHALLENGER #450	Apr 12, 1983	Substantially Equivalent	Transmed, Inc.
K822362	ALTA II ECG RECORDER	Jan 14, 1983	Substantially Equivalent	Scole Engineering Co.
K823414	HOLTER KIT MODEL #5000 SERIES	Dec 30, 1982	Substantially Equivalent	Andover Medical, Inc.
K822818	HOLTER RECORDER & PLAYBACK/ANALYSIS SYS	Dec 30, 1982	Substantially Equivalent	Marquette Electronics, Inc.
K822970	HOLTER RECORDER	Nov 03, 1982	Substantially Equivalent	Agilent Technologies
K822363	ALTA III ECG RECORDER	Oct 04, 1982	Substantially Equivalent	Scole Engineering Co.
K820256	MEDILAC #SR4 & SR 40	Jun 25, 1982	Substantially Equivalent	Spelna, Inc.
K821516	TRACKER-2 CHANNEL ECG TAPE RECORDER	May 28, 1982	Substantially Equivalent	Reynolds Medical , Ltd.
K821453	CARDIOCASSETTE II #363	May 25, 1982	Substantially Equivalent	Birtcher Corp.
K813602	HOLTER PERFORMER	Jan 29, 1982	Substantially Equivalent	Applied Cardiac Systems
K812920	EVENT MASTER	Dec 02, 1981	Substantially Equivalent	Instruments For Cardiac Research
K812763	ECG MEDATAPE-601	Oct 20, 1981	Substantially Equivalent	Hospital Equipment Service
K811253	CASSETTE READER	Jul 10, 1981	Substantially Equivalent	American Edwards Laboratories
K810698	PHARMALOG	Apr 10, 1981	Substantially Equivalent	Circadian, Inc.
K803224	ADVANCEMED HOLTER RECORDERS	Jan 13, 1981	Substantially Equivalent	American Edwards Laboratories
K803222	ADVANCEMED CCU DOCUMENTOR	Jan 13, 1981	Substantially Equivalent	American Edwards Laboratories
K802564	MEDICAL MAGNETIC TAPE RECORDER	Nov 12, 1980	Substantially Equivalent	Medical Concepts, Inc.
K801832	MODEL 9200 VIS-U-SCAN	Aug 27, 1980	Substantially Equivalent	Del Mar Avionics
K801001	AMBULATORY MONITOR AM-1	May 28, 1980	Substantially Equivalent	Burdick Corp.
K800214	CIRCAMED I	Feb 29, 1980	Substantially Equivalent	Circadian, Inc.
K792079	MODEL 447 ELECTROCARDIOCORDER	Dec 27, 1979	Substantially Equivalent	Del Mar Avionics
K792078	MODEL 449 ELECTROCARDIOCORDER	Dec 27, 1979	Substantially Equivalent	Del Mar Avionics
K792076	MODEL 448 PACERCORDER	Dec 27, 1979	Substantially Equivalent	Del Mar Avionics
K790757	LIFEPAK 5 MONITOR, CASSETTE, #800923-01	Jun 01, 1979	Substantially Equivalent	Physio-Control Corp.
K790476	QUICKSCAN HOLTER II	Jun 01, 1979	Substantially Equivalent	Intl. Medical, Inc.
K790509	CARDIOCASSETTE II, AMBULATORY ECG SYSTEM	Mar 23, 1979	Substantially Equivalent	Cambridge Instruments, Inc.
K790289	PB-4 REPLAY UNIT	Feb 27, 1979	Substantially Equivalent	Oxford Medilog, Inc.
K790286	RECORDER, MEDILOG II	Feb 27, 1979	Substantially Equivalent	Oxford Medilog, Inc.
K781843	RECORDER, HOLTER ELECTROCARDIOGRAM	Nov 03, 1978	Substantially Equivalent	Hovik Corp.
K772027	CARDIOCASSETTE II	Nov 09, 1977	Substantially Equivalent	Cardiodyne, Inc.
K771932	RECORDER, DINMAP, MODEL 950	Nov 07, 1977	Substantially Equivalent	Applied Medical Research
K761074	DYNAMIC RECORDER (DR-10)	Dec 28, 1976	Substantially Equivalent	Eldeco
K760508	ACCUTAPE 24	Aug 30, 1976	Substantially Equivalent	Medcraft Corp.