Product Code: DXH FDA class 2 21 CFR 870.2920

Transmitters And Receivers, Electrocardiograph, Telephone

Cardiovascular

The Telephone Electrocardiograph Transmitter and Receiver is a cardiovascular telemonitoring device used to transmit ECG signals from a remote location to a receiving center via telephone or similar communication lines, enabling remote cardiac rhythm analysis and event 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 DXH and it is regulated under 21 CFR 870.2920 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

297

FEI Numbers

Registration Numbers

Unique Applicants

145

Years Active

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Basic Information

Product Code: DXH
Device Class: FDA class 2
Regulation Number: 870.2920
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 297 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250233	PreemptiveAI Clinical SDK	Feb 13, 2026	Substantially Equivalent	Measure Labs, Inc. (Dba Preemptiveai, Inc.)
K250258	HeartBeam AIMIGo with 12-L ECG Synthesis Software System	Dec 08, 2025	Substantially Equivalent	Heartbeam, Inc.
K243438	MEMO Patch M (MPT-E08R-UNC01)	Dec 05, 2025	Substantially Equivalent	Huinno Co., Ltd.
K243981	Hexoskin Medical System (7100-00016)	Nov 18, 2025	Substantially Equivalent	Carre Technologies, Inc.
K243003	VitalSigns 1-Lead Holter (VSH101)	Jun 17, 2025	Substantially Equivalent	VitalSigns Technology Co., Ltd.
K233521	QT ECG (QTERD100)	Dec 06, 2023	Substantially Equivalent	QT Medical, Inc.
K222842	V-Patch Cardiac Monitor	Oct 20, 2022	Substantially Equivalent	Shandong Corecare Technology Limited
K220795	QT ECG	Sep 26, 2022	Substantially Equivalent	QT Medical, Inc.
K213357	Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor	Jul 19, 2022	Substantially Equivalent	Verily Life Sciences, LLC
K220350	KardiaMobile 6L	May 25, 2022	Substantially Equivalent	AliveCor, Inc.
K211668	KardiaMobile Card	Nov 30, 2021	Substantially Equivalent	AliveCor, Inc.
K212160	SimpleSENSE Platform	Sep 22, 2021	Substantially Equivalent	Nanowear, Inc.
K210753	KardiaMobile 6L	Jun 30, 2021	Substantially Equivalent	AliveCor, Inc.
K201669	SimpleSENSE	Nov 06, 2020	Substantially Equivalent	Nanowear, Inc.
K193296	eCordum Cardiac Monitor (eCordum CM)	Oct 30, 2020	Substantially Equivalent	Ecordum, Inc.
K201208	Halo AF Detection System	Sep 23, 2020	Substantially Equivalent	Livmor
K191406	KardiaMobile, KardiaStation	Jan 24, 2020	Substantially Equivalent	AliveCor, Inc.
K192415	Study Watch with Irregular Pulse Monitor	Jan 17, 2020	Substantially Equivalent	Verily Life Sciences, LLC
K183319	Triangle System	May 10, 2019	Substantially Equivalent	AliveCor, Inc.
K182396	KardiaMobile, KardiaStation	Apr 12, 2019	Substantially Equivalent	AliveCor, Inc.
K181310	HeartCheck Cardi Beat ECG Monitor with GEMS Mobile	Feb 22, 2019	Substantially Equivalent	Cardiocomm Solutions, Inc.
K183704	RX-1 Rhythm Express Remote Cardiac Monitoring System	Feb 16, 2019	Substantially Equivalent	VivaQuant, Inc.
K182040	Coala Heart Monitor	Feb 08, 2019	Substantially Equivalent	Coala Life AB
K182456	Study Watch	Jan 17, 2019	Substantially Equivalent	Verily Life Sciences, LLC
K173589	Prizma	Nov 30, 2018	Substantially Equivalent	G-Medical Innovations , Ltd.
K173872	FibriCheck	Sep 28, 2018	Substantially Equivalent	Qompium NV
K173248	CARDIOSKIN	Aug 11, 2018	Substantially Equivalent	Bioserenity Sas
K180157	QT ECG	May 04, 2018	Substantially Equivalent	QT Medical, Inc.
K172311	BioFlux Device	Dec 15, 2017	Substantially Equivalent	Biotricity, Inc.
K171816	Kardia Band System	Nov 16, 2017	Substantially Equivalent	AliveCor, Inc.
K172801	ECG SENTINEL System	Oct 18, 2017	Substantially Equivalent	Cardiomedix, Inc.
K170506	ECG Check - Universal, ECG Check - Universal Plus	Oct 02, 2017	Substantially Equivalent	Cardiac Designs, Inc.
K170181	Prizma	Sep 01, 2017	Substantially Equivalent	G-Medical Innovations , Ltd.
K161431	SimplECG	Nov 30, 2016	Substantially Equivalent	Nanowear, Inc.
K151013	Vitaphone Tele ECG Loop Recorder	Apr 30, 2015	Substantially Equivalent	Vitasystems GmbH
K143032	eMotion Faros ECG Mobile	Mar 29, 2015	Substantially Equivalent	Mega Electronics , Ltd.
K142476	Master Caution Device MCD	Feb 17, 2015	Substantially Equivalent	Healthwatch , Ltd.
K142743	AliveCor Heart Monitor	Jan 27, 2015	Substantially Equivalent	AliveCor, Inc.
K142672	AliveCor Heart Monitor	Dec 03, 2014	Substantially Equivalent	AliveCor, Inc.
K133703	PHYSIOGLOVE ET SYSTEM	Aug 18, 2014	Substantially Equivalent	Commwell R&D , Ltd.
K140933	ALIVECOR HEART MONITOR	Aug 15, 2014	Substantially Equivalent	AliveCor, Inc.
K141813	RHYTHMSTAR SYSTEM	Aug 05, 2014	Substantially Equivalent	RhythMedix, LLC
K130878	CLOUDEKG	Apr 04, 2014	Substantially Equivalent	Makromed, Inc.
K132206	MELYS ATRIAL FIBRILLATION SCREENING MONITOR	Mar 19, 2014	Substantially Equivalent	Advanced Fluidics, LLC
K131699	EMOTION ECG MOBILE	Nov 26, 2013	Substantially Equivalent	Mega Electronics , Ltd.
K121628	EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)	Jun 25, 2013	Substantially Equivalent	Epi Mobile Health Solutions (S) Pte, Ltd.
K122184	ECG CHECK	Feb 14, 2013	Substantially Equivalent	Cardiac Designs, LLC
K113514	SMARTHEART	Feb 22, 2012	Substantially Equivalent	Shl Telemedicine International , Ltd.
K100383	VITAPHONE. MODEL 100 BT	Apr 20, 2010	Substantially Equivalent	Vitasystems GmbH
K093976	RAISIN PERSONAL MONITOR	Mar 25, 2010	Substantially Equivalent	Proteus Biomedical, Inc.
K083174	HEALTHEPOD	Dec 17, 2009	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K083630	CLUE MEDICAL AND CLUE MEDICAL BASIC	Apr 23, 2009	Substantially Equivalent	Telovital GmbH Telemedizin
K083535	HEARTRAK SMART ECAT	Dec 15, 2008	Substantially Equivalent	Universal Medical, Inc.
K082718	TEMPUSIC PATIENT MONITOR	Oct 10, 2008	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.
K082077	BT3/6, BT12	Sep 02, 2008	Substantially Equivalent	Corscience GmbH & Co. KG
K080047	CARDIOSEN'C	Jul 11, 2008	Substantially Equivalent	Shl Telemedicine International , Ltd.
K081471	ECARD AND CCARD	Jun 24, 2008	Substantially Equivalent	iRhythm Technologies, Inc.
K071130	HEARTRAK AF	May 14, 2008	Substantially Equivalent	Universal Medical, Inc.
K072385	HEARTEVENT, MODEL AT	Jan 11, 2008	Substantially Equivalent	Diagnostic Devices Pty, Ltd.
K071228	FIDELITY 200 CARDIAC EVENT RECORDER	Nov 21, 2007	Substantially Equivalent	Signalife, Inc.
K063609	RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER	Sep 12, 2007	Substantially Equivalent	Shl Telemedicine International , Ltd.
K062397	SENTINEL	Jan 25, 2007	Substantially Equivalent	Del Mar Reynolds Medical, Ltd.
K061780	TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +	Sep 15, 2006	Substantially Equivalent	Rozinn Electronics, Inc.
K060911	CG-6108 ARRHYTHMIA ECG EVENT RECORDER	Aug 22, 2006	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K060297	PEPER	Aug 02, 2006	Substantially Equivalent	Medical Monitors, Ltd.
K061977	PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES	Jul 21, 2006	Substantially Equivalent	Pinmed, Inc.
K052767	AFIBALERT ATRIAL FIBRILLATION DETECTOR	Jun 23, 2006	Substantially Equivalent	Lechnologies Research, Inc.
K053378	LOOP RECORDER VITAPHONE, 3100 SERIES	Feb 23, 2006	Substantially Equivalent	Tms Telemedizinische Systeme GmbH
K052556	CG-7000DX-BT ECG RECORDER/TRANSMITTER	Jan 09, 2006	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K051544	VITALCAREGIVING SYSTEM	Oct 07, 2005	Substantially Equivalent	Advanced Monitoring Caregiving, Inc.
K051960	CARDIONAVIGATOR +	Aug 19, 2005	Substantially Equivalent	Del Mar Reynolds Medical, Ltd.
K050951	MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370	Jul 19, 2005	Substantially Equivalent	Cibernet Systems Corp.
K050940	PMP4 MEDICAL WEB CENTER	Jul 01, 2005	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K050670	SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS	Mar 30, 2005	Substantially Equivalent	Tms Telemedizinische Systeme GmbH
K042254	PMP4 SELFCHECK ECG	Jan 13, 2005	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K040942	VST3	Sep 15, 2004	Substantially Equivalent	Biowatch Medical, Inc.
K042022	E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER	Aug 12, 2004	Substantially Equivalent	Datrix, Inc. Dba of Jon Barron, Inc.
K041308	REMOTENURSE PATIENT MONITORING SYSTEM	Jun 28, 2004	Substantially Equivalent	Webvmc, LLC
K033410	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	Mar 05, 2004	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.
K033451	HEARTRAK SMART AT/HEARTRAK SMART2	Feb 05, 2004	Substantially Equivalent	Universal Medical, Inc.
K032736	HEART 2006	Oct 03, 2003	Substantially Equivalent	Aerotel Medical Systems (1998) , Ltd.
K031229	TELZUIT CARDIAC MONITORING SYSTEM	Jul 09, 2003	Substantially Equivalent	Telzuit Technologies, Inc.
K030218	PER, MODEL MEMO	Jun 23, 2003	Substantially Equivalent	Medical Monitors Pty., Ltd.
K020534	MEDSTAR SYSTEM, MODELS 533-300	Feb 11, 2003	Substantially Equivalent	Cybernet Medical
K023689	CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM	Jan 17, 2003	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K024365	TM2005 PERSONAL MEDICAL PHONE CENTER	Jan 15, 2003	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K023418	HEARTONE EVENT RECORDER AND TRANSMITTER	Nov 06, 2002	Substantially Equivalent	Aerotel Medical Systems (1998) , Ltd.
K022073	HEARTLINE RECEIVING STATION	Jul 24, 2002	Substantially Equivalent	Aerotel Medical Systems (1998) , Ltd.
K020213	NETLINK/NETSCAN	Apr 05, 2002	Substantially Equivalent	Rozinn Electronics, Inc.
K013879	TM2000, MODEL 1	Feb 01, 2002	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K012012	ECG HOME	Jan 17, 2002	Substantially Equivalent	H&C Medical Devices Spa
K013175	TM2000 EASYTRACE PLUS RECEIVING CENTER	Oct 30, 2001	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K012223	CG-2211 SELFCHECK ECG TRANSMITTER	Sep 10, 2001	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K012407	PACEART TX3 CARDIAC EVENT RECORDER	Aug 14, 2001	Substantially Equivalent	Paceart, Inc.
K012187	CG-3250 MINIRECEIVER	Aug 14, 2001	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K011345	CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM	Jul 20, 2001	Substantially Equivalent	Reynolds Medical , Ltd.
K010945	HEARTCARD, MODEL 5258	Jun 12, 2001	Substantially Equivalent	Instromedix
K010791	REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)	Jun 08, 2001	Substantially Equivalent	Adsis , Ltd.
K010436	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011	May 14, 2001	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.
K010794	BRIDGE III RECEIVER	May 10, 2001	Substantially Equivalent	Meridian Medical Technologies , Ltd.
K001634	CARDIOSENTRY EVENT MONITOR, MODEL 8470-01	Dec 21, 2000	Substantially Equivalent	Tz Medical, Inc.
K003220	PERSONAL ECG TRANSMITTER, MODEL CG-6550	Nov 08, 2000	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K002310	CARDIOBEEPER CB12/12, MODEL CB12/12	Oct 25, 2000	Substantially Equivalent	Meridian Medical Technologies , Ltd.
K002004	ZYBIT	Sep 21, 2000	Substantially Equivalent	Zymed Medical Instrumentation
K001091	CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01	Aug 10, 2000	Substantially Equivalent	Next Millennium Software Solutions, Inc.
K000775	HEART 2005	May 17, 2000	Substantially Equivalent	Aerotel Medical Systems (1998) , Ltd.
K000225	CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306	Feb 11, 2000	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K994009	CG-2100 ECG TRANSMITTER	Dec 21, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K993799	CG-7000DX ECG RECORDER/TRANSMITTER	Dec 10, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K992696	ECG MINIMONITOR, MODEL CG-5000	Oct 07, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K992772	CARDIOPHONICS 1000 MEMORY MONITOR	Sep 17, 1999	Substantially Equivalent	Rlt Medical Assoc., Inc.
K990478	CARD GUARD, MODEL CG-6550	Aug 31, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K992164	TELEMEDICINE 2000	Aug 30, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K991211	EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM	Jul 08, 1999	Substantially Equivalent	Reynolds Medical , Ltd.
K991307	TELEMEDICINE 2000	Jun 14, 1999	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K982034	E-FAX SYSTEM	Feb 19, 1999	Substantially Equivalent	Blakbag, Ltd., Division of Coherent Systems
K983626	KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II	Feb 05, 1999	Substantially Equivalent	Alaris Medical Systems, Inc.
K982090	PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM	Jan 26, 1999	Substantially Equivalent	Paceart, Inc.
K982228	FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25	Jan 14, 1999	Substantially Equivalent	Tz Medical, Inc.
K983026	PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000	Dec 02, 1998	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K983582	CARDIOBEEPER CB250	Nov 13, 1998	Substantially Equivalent	Merdian Medical Technologies , Ltd.
K981119	CARDIOPAL MODEL NUMBER PM20	Oct 14, 1998	Substantially Equivalent	Medicomp, Inc.
K981394	BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720	Sep 28, 1998	Substantially Equivalent	Braemar Corp.
K980144	HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER	Jun 16, 1998	Substantially Equivalent	Aerotel, Ltd.
K980624	CARDIOSTATION	May 11, 1998	Substantially Equivalent	Universal Medical, Inc.
K973267	TTM5000 TELEPHONIC EKG MONITOR	Jan 29, 1998	Substantially Equivalent	Hds Medical, Inc.
K973863	MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR	Jan 02, 1998	Substantially Equivalent	Hi-Tronics Designs, Inc.
K971696	SENTINEL RECORDER, MODELS 471/472	Dec 30, 1997	Substantially Equivalent	Del Mar Avionics
K972649	CARDIOCALL CARDIAC EVENT RECORDER	Dec 04, 1997	Substantially Equivalent	Reynolds Medical , Ltd.
K971650	RHYTHMSTAT XL	Dec 04, 1997	Substantially Equivalent	Data Critical Corp.
K973141	HEART ACCESS PLUS CARDIAC EVENT RECORDER	Nov 12, 1997	Substantially Equivalent	Paceart, Inc.
K963725	MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)	Sep 10, 1997	Substantially Equivalent	Card Guard , Ltd.
K970305	PRINTER INTERFACE	Aug 15, 1997	Substantially Equivalent	Micromedical, Inc.
K964836	CARD GUARD, MODEL CG-7100	Jul 28, 1997	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K964036	CARDIOMAGIC 2000 SOFTWARE	Jul 18, 1997	Substantially Equivalent	Instromedix, Inc.
K963904	P.H.D. - PERSONAL HEART DEVICE MODEL 5258	May 15, 1997	Substantially Equivalent	Heart Alert, Inc.
K962937	CARDIO TEAM II	Apr 10, 1997	Substantially Equivalent	Vision Electronics
K965101	CARDIOBEEPER CB-12L	Mar 17, 1997	Substantially Equivalent	Meridian Medical Technologies, Inc.
K964888	HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II	Feb 28, 1997	Substantially Equivalent	Tz Medical, Inc.
K963375	CARDIACMONITOR	Feb 28, 1997	Substantially Equivalent	Vision Electronics
K963811	CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE	Dec 04, 1996	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K954350	CARD GUARD MODEL CG-6500	Sep 10, 1996	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K960499	HEARTRAK XL	Aug 06, 1996	Substantially Equivalent	Universal Medical, Inc.
K953762	HEART 400 ECG TRANSMITTER	Jul 18, 1996	Substantially Equivalent	Aerotel, Ltd.
K954163	RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER	Jul 11, 1996	Substantially Equivalent	Cardiac Evaluation Center, Inc.
K961362	AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE	Jul 10, 1996	Substantially Equivalent	Aerotel, Ltd.
K954495	PACETRAK PLUS	Apr 22, 1996	Substantially Equivalent	Universal Medical, Inc.
K955060	ACCELERATED TRANSMISSION PROTOCOL	Apr 08, 1996	Substantially Equivalent	Instromedix, Inc.
K952065	PACEART CARDIOVOICE	Jan 16, 1996	Substantially Equivalent	Paceart, Inc.
K951096	LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER	Jan 16, 1996	Substantially Equivalent	Instromedix, Inc.
K945476	HEARTHWATCH III(TM)	Nov 09, 1995	Substantially Equivalent	Instromedix, Inc.
K950003	CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS	Oct 31, 1995	Substantially Equivalent	Instromedix, Inc.
K944362	HEARTCARD CARDIAC EVENT MONITOR	Sep 07, 1995	Substantially Equivalent	Instromedix, Inc.
K941898	MEMORYTRACE ATM MODEL 4222	Jun 26, 1995	Substantially Equivalent	Hi-Tronics Designs, Inc.
K942586	CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)	May 10, 1995	Substantially Equivalent	Telescan Medical Systems
K943124	HEARTRAK	May 03, 1995	Substantially Equivalent	Universal Medical, Inc.
K943123	PACETRAK	May 03, 1995	Substantially Equivalent	Universal Medical, Inc.
K935909	CG-1000 PERSONAL ECG TRANSMITTER	Apr 28, 1995	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K934975	TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER	Apr 06, 1995	Substantially Equivalent	Rlt Medical Assoc., Inc.
K943931	CARRYALL ENHANCEMENTS	Apr 04, 1995	Substantially Equivalent	Instromedix, Inc.
K943995	IMD PSD 410 PACEMAKER TRANSMITTER	Mar 07, 1995	Substantially Equivalent	Integrated Medical Devices, Inc.
K931020	HEART 1001	Jan 11, 1995	Substantially Equivalent	Aerotel, Ltd.
K942704	CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER	Dec 05, 1994	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K935586	PRINCE	Nov 08, 1994	Substantially Equivalent	Instromedix, Inc.
K924486	CARD GUARD, MODEL CG-9000	Oct 31, 1994	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K932046	LIFE-TELL T.S.S.	Aug 29, 1994	Substantially Equivalent	Raco Products Co.
K933021	MODEL T131 MEMORY TRANSMITTER	Jun 06, 1994	Substantially Equivalent	Biometric Products, Inc.
K926515	CARD GUARD MODEL CG-8000	Mar 30, 1994	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K930314	HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE	Mar 18, 1994	Substantially Equivalent	Aerotel, Ltd.
K932863	E-FAX REMOTE MONITOR	Mar 16, 1994	Substantially Equivalent	Coherent Systems, Inc.
K933012	MXT-2 12 LEAD MICRO-TRANSMITTER	Mar 14, 1994	Substantially Equivalent	Medical Electronic Record Exchange
K931585	CORFAX CARDIAC DATA TRANSMITTER	Mar 07, 1994	Substantially Equivalent	Ralin Medical, Inc.
K932859	E-FAX RECEIVER	Feb 24, 1994	Substantially Equivalent	Coherent Systems, Inc.
K931296	PACEART CARDIOPHONE	Oct 01, 1993	Substantially Equivalent	Paceart, Inc.
K925639	CARDIOMAGIC SOFTWARE	Jun 22, 1993	Substantially Equivalent	Instromedix, Inc.
K924187	INSTANT MEMORY 2000	Jun 16, 1993	Substantially Equivalent	Telescan Medical Systems
K925535	CARDIOBEEPER(R) CB-IIA	Jan 28, 1993	Substantially Equivalent	Survival Technology, Inc.
K922783	ES1700 ECG MODULATOR	Jan 07, 1993	Substantially Equivalent	Epic Systems, Inc.
K921699	ES 1500 ECG DEMODULATOR	Dec 17, 1992	Substantially Equivalent	Epic Systems, Inc.
K923930	ELECTROCARDIOGRAPH TRANSMITTER	Oct 21, 1992	Substantially Equivalent	Tz Medical, Inc.
K920984	KING OF HEARTS EXPRESS (E.X.) MONITOR	Oct 14, 1992	Substantially Equivalent	Instromedix, Inc.
K923493	LIFE-TEL T.R.S.	Sep 23, 1992	Substantially Equivalent	Raco Products Co.
K921929	GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)	Sep 18, 1992	Substantially Equivalent	General Devices
K920765	EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200	Jul 07, 1992	Substantially Equivalent	Electronic Monitoring Devices, Inc.
K922412	ECG MODULATOR	Jul 06, 1992	Substantially Equivalent	Maguire Ent., Inc.
K915224	CARDIOPHONICS MEMORY TRANSMITTER	Feb 07, 1992	Substantially Equivalent	Rlt Medical Assoc., Inc.
K915769	MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR	Jan 30, 1992	Substantially Equivalent	Medtronic Vascular
K915472	ELECTROCARDIOGRAPH TRANSMITTER	Jan 24, 1992	Substantially Equivalent	Tz, Inc.
K912281	ES1600 PARAMEDIC TELEPHONE	Nov 19, 1991	Substantially Equivalent	Epic Systems, Inc.
K913533	MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)	Nov 07, 1991	Substantially Equivalent	Hewlett-Packard Co.
K911308	CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE	Sep 11, 1991	Substantially Equivalent	Medical Equipment Designs, Inc.
K913400	MODEL SCR-1000	Aug 21, 1991	Substantially Equivalent	Accucore, Inc.
K912084	MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221	Jul 30, 1991	Substantially Equivalent	Medtronic Vascular
K904966	DATAMED MODEL 401A TRANSRECIEVER	Jul 18, 1991	Substantially Equivalent	Datamed, Inc.
K912379	PDT CARRYALL TRANSMITTER, VARIOUS MODELS	Jun 17, 1991	Substantially Equivalent	Cardiac Pacemakers, Inc.
K910451	CARD GUARD, MODEL CG-2000A	Jun 10, 1991	Substantially Equivalent	Medtech Industries, Inc.
K910450	CARD GUARD-3000 ECG TELEPHONE ADAPTER	May 07, 1991	Substantially Equivalent	Medtech Industries, Inc.
K904250	MODEL 4222 AMBULATORY ECG MONITOR	Feb 25, 1991	Substantially Equivalent	Byrncrest Global, Inc.
K903960	MODEL 9444 TELETRACE II ECG MONITORING SYSTEM	Oct 09, 1990	Substantially Equivalent	Medtronic Vascular
K902254	ESCORT MODEL 400T TELEMETRY ECG MONITOR	Jul 27, 1990	Substantially Equivalent	Medical Data Electronics
K900541	LIFE-TEL CELLULAR TRANSCEIVER	Jul 13, 1990	Substantially Equivalent	Racom, Inc.
K901591	ESCORT-LINK (MODEL E3200)	May 15, 1990	Substantially Equivalent	Medical Data Electronics
K896040	KING OF HEARTS CDM	May 15, 1990	Substantially Equivalent	Instromedix, Inc.
K895719	TELEREHAB SYSTEM FOR CARDIAC REHABILITATION	Mar 06, 1990	Substantially Equivalent	Scottcare Corp.
K896039	KING OF HEARTS 1200 MONITOR	Feb 28, 1990	Substantially Equivalent	Instromedix, Inc.
K896002	CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER	Jan 19, 1990	Substantially Equivalent	Instromedix, Inc.
K894856	CARDIOPHONE	Jan 18, 1990	Substantially Equivalent	Euro-American Marketing Group, Inc.
K894540	TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000	Oct 12, 1989	Substantially Equivalent	Physio-Control Corp.
K894799	CARDIOBEEPER MEMORY MONITOR CB 600 SERIES	Oct 03, 1989	Substantially Equivalent	Survival Technology, Inc.
K894340	PCI MODEL 2041-A TELEMETRY MONITOR	Oct 02, 1989	Substantially Equivalent	Accucore, Inc.
K894277	M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME	Sep 26, 1989	Substantially Equivalent	Hewlett-Packard Co.
K893471	MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING	Sep 26, 1989	Substantially Equivalent	Medtronic Vascular
K892370	DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM	Aug 28, 1989	Substantially Equivalent	Bio-Focus, Inc.
K894140	MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER	Jul 27, 1989	Substantially Equivalent	Medtronic Vascular
K890558	WELLSHIRE BASELINK	Mar 09, 1989	Substantially Equivalent	American Executive Technology
K890508	WELLSHIRE EMLINK MODEL 1000	Mar 02, 1989	Substantially Equivalent	American Executive Technology
K890461	CARDIOBEEPER IV	Feb 23, 1989	Substantially Equivalent	Survival Technology, Inc.
K884142	OXINET N-7500 PULSE OXIMETRY NETWORK	Dec 16, 1988	Substantially Equivalent	Nellcor, Inc.
K883843	CARDIOBEEPER II	Nov 09, 1988	Substantially Equivalent	Survival Technology, Inc.
K881772	SENSOCOR(TM) R-TEST 240 XL	Nov 09, 1988	Substantially Equivalent	Sensormedix, Inc.
K883358	TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM	Oct 13, 1988	Substantially Equivalent	Telescan Medical Systems
K880971	DIGITAL MEDICINE ECG MONITOR AND RECORDER	Aug 30, 1988	Substantially Equivalent	Digital Medicine Systems
K882119	TELSTETH TELEMETRIC STETHOSCOPE(TM)	Aug 08, 1988	Substantially Equivalent	Quantsonics, Inc.
K882290	CARD GUARD, MODEL CG-2000	Jul 22, 1988	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K881986	ESCORT - PORTABLE PATIENT MONITOR	Jul 12, 1988	Substantially Equivalent	Medical Data Electronics
K880615	AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30	May 13, 1988	Substantially Equivalent	Cardiotechnics, Inc.
K880533	VITEL III CM	May 13, 1988	Substantially Equivalent	Equimed Corp.
K880300	CARDIOBEEPER(R) III	May 12, 1988	Substantially Equivalent	Survival Technology, Inc.
K880626	KING OF HEARTS	Apr 11, 1988	Substantially Equivalent	Instromedix, Inc.
K880283	PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS	Mar 09, 1988	Substantially Equivalent	Paceart, Inc.
K874387	PCI MODEL RS100 TELEMETRY MONITOR	Dec 18, 1987	Substantially Equivalent	Accucore, Inc.
K872869	STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)	Nov 04, 1987	Substantially Equivalent	Labeltape Meditect, Inc.
K870652	MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR	May 14, 1987	Substantially Equivalent	Medtronic Vascular
K870527	CARDIOTEAM	Apr 20, 1987	Substantially Equivalent	Cardiac Network, Inc.
K864293	HEART TRACK	Mar 23, 1987	Substantially Equivalent	Cardio Telemetric Systems, Inc.
K862668	HEALTHPHONE(TM)	Dec 22, 1986	Substantially Equivalent	Carelink
K854369	WEP 7604 TELEMETRY MONITOR	Feb 28, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K854013	TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE	Feb 28, 1986	Substantially Equivalent	Medrand, Inc.
K853096	CMS 8000	Jan 22, 1986	Substantially Equivalent	Physio-Control Corp.
K851623	MODEL TRC-40 TELEMETRY RECIEVER MODULE	Jan 22, 1986	Substantially Equivalent	Eaton Medical Group
K851624	MODEL TT-185 TELEMETRY TRANSMITTER	Jan 14, 1986	Substantially Equivalent	Eaton Medical Group
K852971	#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER	Oct 22, 1985	Substantially Equivalent	Medtronic Vascular
K842435	MODEL T 101 CLINICAL TRANSMITTER	May 16, 1985	Substantially Equivalent	Biometric Products, Inc.
K851124	T-1000 ECG TRANSMITTER	May 15, 1985	Substantially Equivalent	Brentwood Instruments, Inc.
K851123	R-1000 ECG RECEIVER	May 15, 1985	Substantially Equivalent	Brentwood Instruments, Inc.
K844966	CARDIOBEEPER PROFILE MONITOR	Feb 08, 1985	Substantially Equivalent	Survival Technology, Inc.
K842716	MDE ESCORT 1000 & MDE ESCOR 2000	Feb 08, 1985	Substantially Equivalent	Medical Data Electronics
K844391	NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS	Jan 07, 1985	Substantially Equivalent	Ams Medical, Inc.
K842370	PAGE-WRITER INTERPRETIVE CARDIOGRAPH	Dec 07, 1984	Substantially Equivalent	Hewlett-Packard Co.
K840587	INSTANT REPLAY	Oct 26, 1984	Substantially Equivalent	Instromedix, Inc.
K840032	TELEPHONE RECEIVERS R101 R111	Oct 26, 1984	Unknown	Biometric Products, Inc.
K834034	MODEM ACCESSORY FOR EPI CARDIA SYS	May 09, 1984	Substantially Equivalent	Medicomp, Inc.
K832951	MEMORY LOOP TRANSMITTER #121	Feb 17, 1984	Substantially Equivalent	Biometric Products, Inc.
K831443	PACELINE PATIENT TRANSMITTER MODEL 324	Aug 12, 1983	Substantially Equivalent	Pacesetter Systems
K830903	CARDIO ARRHYTHMIA TRANSMITTER C.A.T	Jul 26, 1983	Substantially Equivalent	Cardio Technology , Ltd.
K831092	PECGASYS REMOTE TRANSMISSION UNIT	Jul 19, 1983	Substantially Equivalent	Datamedix
K830254	LIFE LINE	May 18, 1983	Substantially Equivalent	Kb & Assoc.
K830477	CARDIOMEMO III	May 09, 1983	Substantially Equivalent	Instromedix, Inc.
K830028	SIRECUST 456	Jan 21, 1983	Substantially Equivalent	Analogic Corp.
K822955	MODEL 4242 TELE SYST ARRHYTHMIA MONITOR	Nov 01, 1982	Substantially Equivalent	Medtronic Vascular
K821726	MODEL 535-02 TRACE-A-PACE TRANSMITTER	Jul 08, 1982	Substantially Equivalent	Intermedics, Inc.
K820986	EKG MONITORS, VARIOUS MODELS	Apr 29, 1982	Substantially Equivalent	Dart Medical Equipment
K820904	EKG TELEPHONE CONVERTER	Apr 21, 1982	Substantially Equivalent	Dart Medical Equipment
K820452	PHONOTRACE 2000	Apr 16, 1982	Substantially Equivalent	Lowrance Electronics, Inc.
K820828	SAMM	Apr 14, 1982	Substantially Equivalent	Dart Medical Equipment
K820276	TELESCAN T-30	Feb 12, 1982	Substantially Equivalent	Telescan Medical Systems
K812793	P.E.T.	Jan 18, 1982	Substantially Equivalent	Hospital Equipment Service
K812755	MODEL 535-03 TRACE A PACE	Nov 16, 1981	Substantially Equivalent	Intermedics, Inc.
K812703	MODEL 9408 A TELETRACE	Oct 23, 1981	Substantially Equivalent	Medtronic Vascular
K811464	MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY	Sep 23, 1981	Substantially Equivalent	Intermedics, Inc.
K811758	ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR	Aug 03, 1981	Substantially Equivalent	Powers Medical Systmes
K811512	TELETRACE TELEPHONE EKG SYSTEM	Jun 30, 1981	Substantially Equivalent	Medtronic Vascular
K810872	EEG TELEPHONE RECEIVER MODEL #AFR-J	May 01, 1981	Substantially Equivalent	Telediagnostic Systems, Inc.
K810608	TRANSMITTER & RECEIVERS, TELEPHONE, ELEC	May 01, 1981	Substantially Equivalent	Heart Check Systems, Inc.
K803315	CRITERION II RHYTHM PROFILE MONITOR	Jan 22, 1981	Substantially Equivalent	Dart Medical Equipment
K802717	HP MODEL 4710A ECG TRANSMITTER	Jan 22, 1981	Substantially Equivalent	Hewlett-Packard Co.
K802089	CARDIOTRAK	Sep 26, 1980	Substantially Equivalent	Cardiac Pacemakers, Inc.
K801700	UNI-RECORD I	Aug 07, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792359	MEDTRONIC MODEL 9407 TELETRACE TRANSMITT	Dec 05, 1979	Substantially Equivalent	Medtronic Vascular
K792246	MEDTRONIC MODEL 9408 TELETRACE TRANSMIT	Nov 21, 1979	Substantially Equivalent	Medtronic Vascular
K791778	MEDTRONIC MODEL 9410 TELETRACE RECEIVER	Oct 02, 1979	Substantially Equivalent	Medtronic Vascular
K782076	HT-110 MICROMINI	Dec 29, 1978	Substantially Equivalent	Health Tech
K782059	TRANSMITTER, TR-1 ECG	Dec 21, 1978	Substantially Equivalent	Burdick Corp.
K781986	TRANSMITTER, MODEL 9406 AND 9401	Dec 13, 1978	Substantially Equivalent	Medtronic Vascular
K780158	TELETRACE TELEPHONE EKG TRANSMITTER	Mar 21, 1978	Substantially Equivalent	Medtronic Vascular
K772350	PATIENT ALERT MODEL 555	Mar 09, 1978	Substantially Equivalent	Intermedics, Inc.
K772186	ELECTROCARDIOGRAPH TRANSMITTER, 536	Feb 02, 1978	Substantially Equivalent	Intermedics, Inc.
K772178	PACER MONITOR, PULSE WIDTH	Dec 08, 1977	Substantially Equivalent	Survival Technology, Inc.
K771648	COMPUTER ECG TERMINAL	Sep 20, 1977	Substantially Equivalent	Compumed, Inc.
K770949	COMPUTER ECG TELE. TRANSMISSION TERMINAL	Jun 02, 1977	Substantially Equivalent	The Okun Co.
K770264	PACEGUARD	Feb 16, 1977	Substantially Equivalent	Cardio Data
K760857	TR-3 TRANSMITTER	Jan 28, 1977	Substantially Equivalent	Burdick Corp.
K761318	3038 OPTION B-COMPUT. TRANS. TERMINAL	Jan 06, 1977	Substantially Equivalent	Cambridge Instruments, Inc.
K761073	POCKET TRANSMITTER (PT-10)	Dec 28, 1976	Substantially Equivalent	Eldeco
K761066	ECG MONITOR (TELEPHONE ECG TRANSMITTER)	Dec 09, 1976	Substantially Equivalent	Physio-Control Corp.
K760564	DEMODULATOR SERIES 1400	Sep 10, 1976	Substantially Equivalent	Physio-Control Corp.
K760563	ECG MODULATOR	Sep 10, 1976	Substantially Equivalent	Physio-Control Corp.