Product Code: DRG FDA class 2 21 CFR 870.2910

Transmitters And Receivers, Physiological Signal, Radiofrequency

Cardiovascular

The Radiofrequency Physiological Signal Transmitter and Receiver is a cardiovascular telemetry device used to wirelessly transmit and receive physiological signals such as ECG or pressure data between a patient and monitoring equipment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRG and it is regulated under 21 CFR 870.2910 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

189

FEI Numbers

127

Registration Numbers

127

Unique Applicants

131

Years Active

Basic Information

Product Code: DRG
Device Class: FDA class 2
Regulation Number: 870.2910
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 189 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250259	TeleRehab Aermos Cardiopulmonary Rehabilitation	Jun 04, 2025	Substantially Equivalent	The ScottCare Corporation
K243837	iBSM	May 16, 2025	Substantially Equivalent	iOrbit Digital Technologies Private Limited
K242018	UbiqVue 2A Multi-parameter System (UX2550)	Nov 12, 2024	Substantially Equivalent	LifeSignals, Inc.
K241101	BioButton System	Sep 26, 2024	Substantially Equivalent	BioIntelliSense Inc.
K240251	ANNE Chest	Jun 03, 2024	Substantially Equivalent	Sibel Health Inc.
K223711	ANNE One	Aug 10, 2023	Substantially Equivalent	Sibel Health Inc.
K220526	HD+12, HD+15	May 15, 2023	Substantially Equivalent	Cardioline S.P.A
K223073	Alio	Mar 17, 2023	Substantially Equivalent	Alio, Inc.
K222398	Care Team Portal	Feb 06, 2023	Substantially Equivalent	Vivify Health, Inc.
K212957	BioButton System	Dec 12, 2022	Substantially Equivalent	BiolntelliSense Inc.
K221530	ANNE Pediatric	Nov 22, 2022	Substantially Equivalent	Sibel Inc.
K212883	ers2 - ergoline Rehabilitation System	Jul 15, 2022	Substantially Equivalent	ergoline GmbH
K213233	EZYPRO ECG Recorder (Model: UG02)	Jun 23, 2022	Substantially Equivalent	Sigknow Biomedical Co.,Ltd.
K211365	Alio Medical Remote Monitoring System	Mar 24, 2022	Substantially Equivalent	Graftworx, Inc. dba Alio
K211822	LifePath Remote Patient Monitoring Platform	Feb 03, 2022	Substantially Equivalent	Elastic Care Incorporated
K211305	ANNE One	Sep 14, 2021	Substantially Equivalent	Sibel Inc.
K202868	LifeSignals Multi-Parameter Remote Monitoring Platform	Jul 21, 2021	Substantially Equivalent	LifeSignals, Inc.
K200690	LifeSignals ECG Remote Monitoring Patch Platform	Jul 15, 2020	Substantially Equivalent	LifeSignals, Inc.
K191620	Vitls Platform	Jun 01, 2020	Substantially Equivalent	Vitls Inc.
K193343	Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)	Apr 20, 2020	Substantially Equivalent	VitalConnect, Inc.
K192875	Philips Biosensor BX100	Apr 16, 2020	Substantially Equivalent	Philips Medical Systems
K192757	VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20	Feb 06, 2020	Substantially Equivalent	VitalConnect, Inc.
K191870	VV330 Continuous ECG Platform, VivaLNK Adhesive Patch	Jan 07, 2020	Substantially Equivalent	VivaLNK, Inc.
K191614	BioSticker System	Dec 18, 2019	Substantially Equivalent	BioIntelliSense Inc.
K191331	Life Sensor Cardiac Monitor	Jun 12, 2019	Substantially Equivalent	BraveHeart Wireless, Inc.
K190916	VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20	Jun 07, 2019	Substantially Equivalent	VitalConnect, Inc.
K183078	VitalConnect Platform, VitalPatch Biosensor	Mar 07, 2019	Substantially Equivalent	VitalConnect, Inc.
K182297	Surveyor S2	Jan 24, 2019	Substantially Equivalent	Mortara Instrument Inc
K181248	Comarch e-Care Platform	Oct 22, 2018	Substantially Equivalent	Comarch Healthcare SA
K181196	Caretaker Remote Display App and Caretaker Software Library	Oct 03, 2018	Substantially Equivalent	Caretaker Medical, LLC
K172011	LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)	Jun 14, 2018	Substantially Equivalent	HMicro, Inc.
K171019	ScioCardio ECG Transmitter	May 30, 2018	Substantially Equivalent	Synergen Technology Labs LLC
K173510	BioStamp nPoint	May 08, 2018	Substantially Equivalent	MC10 Inc.
K172329	Patient Status Engine	Apr 23, 2018	Substantially Equivalent	Isansys Lifecare Ltd
K163694	Rooti Rx ECG Event Recorder, Rooti Link APP Software	Nov 07, 2017	Substantially Equivalent	Rooti Labs Ltd.
K163453	VitalPatch® VitalConnect Platform	Nov 02, 2017	Substantially Equivalent	VITAL CONNECT, INC.
K171406	Optum TeleHealth Application	Aug 18, 2017	Substantially Equivalent	United Health Group Inc.
K171029	eCareCoordinator	Jul 14, 2017	Substantially Equivalent	Visicu Inc.
K171188	Ossler Exam Scope	Jun 23, 2017	Substantially Equivalent	LR Med Inc
K170973	VitalWatch Software User Interface	Jun 02, 2017	Substantially Equivalent	VitalConnect, Inc.
K170204	FFR Link, FFR Signal Processing Module	Mar 24, 2017	Substantially Equivalent	Boston Scientific Corporation
K161916	TelePatch Cardiac Monitor	Dec 21, 2016	Substantially Equivalent	MEDICOMP, INC.
K153719	LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream	Jun 03, 2016	Substantially Equivalent	HONEYWELL HOMMED, LLC
K152139	Vital Connect Platform, HealthPatch MD, VitalPatch	Dec 06, 2015	Substantially Equivalent	VITAL CONNECT, INC.
K150289	CARDIOLINE HD+	Aug 27, 2015	Substantially Equivalent	CARDIOLINE S.p.A
K141020	SURVEYOR S4 MOBILE MONITOR	Dec 03, 2014	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K141792	GENESIS TOUCH SYSTEM	Nov 25, 2014	Substantially Equivalent	HONEYWELL HOMMED
K133997	LG SMARTHEALTH	Nov 21, 2014	Substantially Equivalent	LG ELECTRONICS
K141706	ECARE COORDINATOR (ECC)	Sep 09, 2014	Substantially Equivalent	VISICU, INC.
K141167	VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)	Jul 29, 2014	Substantially Equivalent	VITAL CONNECT INC.
K132173	FAMILY HEALTHWARE	May 30, 2014	Substantially Equivalent	SANITAS, INC.
K132930	MYHEALTHPOINT TELEHEALTH MANAGER	Apr 14, 2014	Substantially Equivalent	ENTRA HEALTH SYSTEMS
K132447	VITALCONNECT PLATFORM BY VITAL CONNECT INC.	Apr 03, 2014	Substantially Equivalent	Vital Connect, Inc
K133252	HEALTHINTERLINK BEACON	Mar 14, 2014	Substantially Equivalent	HEALTHINTERLINK, LLC
K134004	VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE	Feb 14, 2014	Substantially Equivalent	CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS
K133587	PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300	Dec 20, 2013	Substantially Equivalent	ST. JUDE MEDICAL SYSTEMS AB
K132803	MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK	Dec 12, 2013	Substantially Equivalent	MEDAPPS INC., DBA ALERE CONNECT
K132148	S HEALTH	Dec 04, 2013	Substantially Equivalent	SAMSUNG ELECTRONICS CO., LTD.
K131913	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	Nov 26, 2013	Substantially Equivalent	PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
K130971	OPTUM TELEHEALTH APPLICATION	Oct 23, 2013	Substantially Equivalent	OPTUMHEALTH CARE SOLUTIONS, INC.
K130821	INTEL-GE CARE INNOVATIONS CONNECT RCM	Aug 09, 2013	Substantially Equivalent	INTEL-GE CARE INNOVATIONS LLC
K124000	MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM	Jul 30, 2013	Substantially Equivalent	MEDAPPS INC., DBA ALERE CONNECT
K122458	VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM	Jul 30, 2013	Substantially Equivalent	CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
K130360	CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION	Jul 15, 2013	Substantially Equivalent	CONSTANT CARE, LLC
K130676	AMBIO REMOTE HEALTH MONITORING SYSTEM	Jul 08, 2013	Substantially Equivalent	ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH
K122763	PHYSIOLOGICAL DATA PROCESSOR	Jun 20, 2013	Substantially Equivalent	ZEPHYR TECHNOLOGY CORPORATION
K130290	MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE	Jun 04, 2013	Substantially Equivalent	INTEL-GE CARE INNOVATIONS LLC
K123671	WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM	Jan 16, 2013	Substantially Equivalent	SANITAS, INC.
K123229	REMOTE PRESENCE SYSTEM, MODEL RP-VITA	Nov 20, 2012	Substantially Equivalent	INTOUCH HEALTH, INC.
K122333	MOBILECARE MONITOR	Nov 19, 2012	Substantially Equivalent	AFRAME DIGITAL, INC.
K122285	TABLET COMMANDER	Aug 14, 2012	Substantially Equivalent	CARDIOCOM LLC
K122095	ICP TRIAGEMANAGER	Jul 26, 2012	Substantially Equivalent	Emergo Europe Consulting BV
K120325	CONNECTED CARE MOBILE APPLICATION	Jul 18, 2012	Substantially Equivalent	WATERMARK MEDICAL
K120253	ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)	Jul 16, 2012	Substantially Equivalent	ELCAM MEDICAL A.C.A.L.
K113446	VIGNET TELEHEALTH MANAGER	Jul 16, 2012	Substantially Equivalent	VIGNET INC.
K120941	CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM	Jul 03, 2012	Substantially Equivalent	CONSTANT CARE, LLC
K120470	MIPAL	Jun 08, 2012	Substantially Equivalent	WATERMARK MEDICAL
K120895	REMOTE PRESENCE SYSTEM	May 24, 2012	Substantially Equivalent	INTOUCH HEALTH, INC.
K120704	3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM	May 03, 2012	Substantially Equivalent	3M COMPANY
K112858	GENESIS TOUCH SYSTEM	Jan 24, 2012	Substantially Equivalent	HONEYWELL HOMMED, LLC
K113493	TCX-I REMOTE CARE MANAGEMENT SYSTEM	Dec 21, 2011	Substantially Equivalent	BL HEALTHCARE, INC.
K112559	MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM	Dec 02, 2011	Substantially Equivalent	MEDAPPS, INC.
K111922	VOCARE MYHEALTH TABLET	Dec 02, 2011	Substantially Equivalent	VOCARE, INC
K111854	AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER	Oct 21, 2011	Substantially Equivalent	ST. JUDE MEDICAL SYSTEMS AB
K103643	ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)	Oct 06, 2011	Substantially Equivalent	ASCOT TECHNOLOGIES, INC.
K103796	TELEMEDCARE HEALTH MONITOR	Aug 03, 2011	Substantially Equivalent	TELEMEDCARE PTY LTD
K110809	WIRELESS MONITORING SYSTEM	Jul 05, 2011	Substantially Equivalent	CAREFUSION 303, INC.
K110334	WALDO PATIENT MONITOR	Apr 12, 2011	Substantially Equivalent	WALDO HEALTH
K103276	INTEL HEALTH GUIDE	Feb 08, 2011	Substantially Equivalent	INTEL CORPORATION DIGITAL HEALTH GROUP
K102106	NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION	Dec 17, 2010	Substantially Equivalent	NIHON KOHDEN CORP.
K103214	M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130	Dec 01, 2010	Substantially Equivalent	LIFELINE SYSTEMS, INC.
K101834	3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM	Sep 03, 2010	Substantially Equivalent	3M COMPANY
K101178	MODIFICATION TO INTEL HEALTH GUIDE PHS6000	Jun 29, 2010	Substantially Equivalent	INTEL CORP.
K101242	GENESIS DM MODEL: 6053000A1	Jun 11, 2010	Substantially Equivalent	HONEYWELL HOMMED, LLC
K100427	FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY	May 28, 2010	Substantially Equivalent	TaiDoc Technology Corporation
K100524	POLYTEL(R) APT MODEL: PWA-08-01	May 24, 2010	Substantially Equivalent	POLYMAP WIRELESS, LLC
K093895	ALLY PLATFORM SYSTEM	May 20, 2010	Substantially Equivalent	CONTINUITY HEALTH SOLUTIONS
K101078	BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM	May 10, 2010	Substantially Equivalent	BL HEALTHCARE, INC.
K100508	CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B	May 05, 2010	Substantially Equivalent	CAREMATIX INC.
K093134	CERNER CAREAWARE IBUS	Nov 27, 2009	Substantially Equivalent	CERNER CORP.
K091696	SAVI WIRELESS, MODEL PM500	Oct 26, 2009	Substantially Equivalent	MEDICOMP, INC.
K091220	HEALTHANYWHERE SYSTEM	Sep 21, 2009	Substantially Equivalent	HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY
K092635	ALCATEL-LUCENT TELEHEATH MANAGER	Sep 10, 2009	Substantially Equivalent	ALCATEL-LUCENT CANADA INC.
K091430	CARE PAL, MODEL CPW-10X	Aug 21, 2009	Substantially Equivalent	DIGIO2 INTERNATIONAL CO., LTD
K091021	MODIFICATION TO MEDICOMPASS CONNECT	Jul 15, 2009	Substantially Equivalent	IMETRIKUS, INC.
K083862	MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM	Jun 05, 2009	Substantially Equivalent	MEDAPPS, INC.
K090886	RTX 3371	Apr 15, 2009	Substantially Equivalent	TUNSTALL HEALTHCARE
K090801	ELECTRONIC HOUSE CALL	Apr 08, 2009	Substantially Equivalent	EXPRESS MD SOLUTIONS, LLC
K090610	HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM	Mar 13, 2009	Substantially Equivalent	HOSPIRA, INC.
K083046	FORA TELEHEALTH SYSTEM	Jan 16, 2009	Substantially Equivalent	TaiDoc Technology Corporation
K081499	HEALTH MANAGER, VERSION 1.1	Jan 16, 2009	Substantially Equivalent	BIOCOMFORT DIAGNOSTICS GMBH & CO. KG
K083331	CONFIDANT, MODEL 2.6	Jan 09, 2009	Substantially Equivalent	CONFIDANT INC.
K083115	MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000	Nov 26, 2008	Substantially Equivalent	INTEL CORP.
K080798	INTEL HEALTH GUIDE, MODEL: PHS6000	Jun 27, 2008	Substantially Equivalent	INTEL CORP.
K073710	INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7	Apr 11, 2008	Substantially Equivalent	INTOUCH TECHNOLOGIES
K080091	MODIFICATION TO:HEALTH BUDDY APPLIANCE	Feb 05, 2008	Substantially Equivalent	HEALTH HERO NETWORK, INC.
K073038	CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B	Jan 11, 2008	Substantially Equivalent	CAREMATIX INC.
K072698	CONFIDANT 2.5	Nov 16, 2007	Substantially Equivalent	CONFIDANT INC.
K072008	BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER	Oct 03, 2007	Substantially Equivalent	BRAEMAR, INC.
K071564	MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921	Aug 31, 2007	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K071953	RTX3370	Aug 08, 2007	Substantially Equivalent	RTX HEALTHCARE A/S
K071058	MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A	Jun 29, 2007	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K070543	MODIFICATION TO HEALTH BUDDY APPLIANCE	Mar 28, 2007	Substantially Equivalent	HEALTH HERO NETWORK, INC.
K063612	MODIFICATION TO HEALTH BUDDY APPLIANCE	Dec 29, 2006	Substantially Equivalent	HEALTH HERO NETWORK, INC.
K063484	PATIENT DATA HANDLER & DEVICES (PDH&D)	Dec 22, 2006	Substantially Equivalent	INTERMED ADVISORS, INC.
K062662	TELEMEDICINE SYSTEM MODEL VMS-01	Nov 21, 2006	Substantially Equivalent	MEDIC4ALL (ISRAEL) LTD.
K062127	MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)	Nov 08, 2006	Substantially Equivalent	MEDIC4ALL (ISRAEL) LTD.
K062215	CONFIDANT 2.0	Oct 16, 2006	Substantially Equivalent	CONFIDANT INC.
K062304	DLM112 DAYLINK MONITOR	Sep 29, 2006	Substantially Equivalent	RTX HEALTHCARE A/S
K061502	MEDIC4ALL TELEMEDICINE SYSTEM VMS-01	Sep 15, 2006	Substantially Equivalent	MEDIC4ALL (ISRAEL) LTD.
K061606	DEFIBRILLATOR CABLE TESTER, MODEL DT2200	Jun 21, 2006	Substantially Equivalent	MEDICAL DEVICES/PADPRO, INC.
K061088	SENTRY OTC MONITOR	Jun 09, 2006	Substantially Equivalent	HONEYWELL HOMMED, LLC
K061087	GENESIS OTC MONITOR	Jun 09, 2006	Substantially Equivalent	HONEYWELL HOMMED, LLC
K052608	TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)	Feb 01, 2006	Substantially Equivalent	BL HEALTHCARE, INC.
K052961	THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN	Nov 18, 2005	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K051470	REMOTE CARE MANAGEMENT SYSTEMS (RCMS)	Jun 08, 2005	Substantially Equivalent	BL HEALTHCARE, INC.
K050929	THE HERMES SYSTEM	May 20, 2005	Substantially Equivalent	PALAISTRA SYSTEMS INC.
K050128	VITALWARE VMS	May 13, 2005	Substantially Equivalent	TELEVITAL, INC.
K050778	TELEREHAD 2004	Apr 13, 2005	Substantially Equivalent	SCOTTCARE
K050567	HEALTH BUDDY APPLIANCE	Apr 05, 2005	Substantially Equivalent	HEALTH HERO NETWORK, INC.
K041816	RTX3320PSTN WIRELESS TELEHEALTH GATEWAY	Jul 19, 2004	Substantially Equivalent	RTX HEALTHCARE A/S
K040663	TELENABLE EMS SYSTEM	Jun 30, 2004	Substantially Equivalent	MOLEX, INC.
K040966	MODIFICATION TO CAREMATIX WELLNESS SYSTEM	Jun 02, 2004	Substantially Equivalent	CAREMATIX INC.
K030222	NX SYSTEM	Aug 19, 2003	Substantially Equivalent	AMERICAN TELECARE, INC.
K030795	LIFESYNE SYSTEMS	Aug 05, 2003	Substantially Equivalent	GMP/COMPANIES, INC.
K022274	CARECOMPANION PATIENT STATION & NURSE STATION	May 29, 2003	Substantially Equivalent	NEPTEC DESIGN GROUP, LTD.
K023749	THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)	Nov 19, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K013533	EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)	Jan 18, 2002	Substantially Equivalent	GENERAL DEVICES
K002514	CADHEALTH SYSTEM, MODEL CHP-001	May 31, 2001	Substantially Equivalent	CADUCEUS HEALTH CARE LTD.
K002089	ROSETTA-LT/ROSETTA-RX	Nov 21, 2000	Substantially Equivalent	GENERAL DEVICES
K000276	MPT 24 AND VITAL VIEW 24	Mar 01, 2000	Substantially Equivalent	CRITICARE SYSTEMS, INC.
K993550	AVIVA SYSTEM, MODEL SL1010	Jan 13, 2000	Substantially Equivalent	AMERICAN TELECARE, INC.
K993169	MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A	Dec 20, 1999	Substantially Equivalent	HEWLETT-PACKARD CO.
K981533	AVIVA SYSTEMS MODEL NUMBERS 1010, 2020	Jul 15, 1998	Substantially Equivalent	AMERICAN TELECARE, INC.
K974149	AMBULATORY X-12 TELEMETRY MODULE	Jan 08, 1998	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K973873	DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1	Dec 29, 1997	Substantially Equivalent	AMERICAN TELECARE, INC.
K964554	PERSONAL TELEMEDICINE MODULE	Dec 17, 1996	Substantially Equivalent	AMERICAN TELECARE, INC.
K946175	NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER	Nov 22, 1995	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K945578	NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER	Nov 14, 1995	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K940009	GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300	Apr 14, 1995	Substantially Equivalent	GENERAL DEVICES
K945037	SIEMENS 1481 T TRANSMITTER, ENHANCED	Mar 21, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K935839	GEMSCOM SERIES 5000,	Nov 10, 1994	Substantially Equivalent	GENERAL DEVICES
K934711	PROPAQ ECG TELEMETRY OPTION	Sep 01, 1994	Substantially Equivalent	PROTOCOL SYSTEMS, INC.
K914889	GEMSCOM SERIES 3000	Mar 04, 1992	Substantially Equivalent	GENERAL DEVICES
K910620	CARDIOCAP DR-124 RECORDER	May 07, 1991	Substantially Equivalent	DATEX DIVISION INSTRUMENTARIUM CORP.
K904748	TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100	Mar 01, 1991	Substantially Equivalent	TRANSTRACHEAL SYSTEMS
K891104	CD TELEMETRY SYSTEMS	Apr 19, 1989	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K880036	BIOMA 5000	Mar 07, 1988	Substantially Equivalent	E.B.S., INC.
K873672	MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR	Dec 03, 1987	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K860239	ORG-7201 MULTIPARAMETER TELEMETRY MONITOR	Jun 26, 1986	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K851302	QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR	May 15, 1985	Substantially Equivalent	QUINTON, INC.
K850166	TELEMANOMETER	Apr 18, 1985	Substantially Equivalent	R.J. ASH, MEDICAL MONITORING, INC.
K844376	MODEL 78210A TELEMETRY TRANSMITTER	Jan 10, 1985	Substantially Equivalent	HEWLETT-PACKARD CO.
K832817	TELEMETRY SYS SERIES 7700 ECG	Jan 10, 1984	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K823906	TELEMETRY SYSTEM	Mar 09, 1983	Substantially Equivalent	TRANSKINETIC SYSTEMS, INC.
K823249	LIFESCOPE II/FOUR	Nov 24, 1982	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K821384	EXERCISE ECG ELECTRODES, REUSABLE	Jun 17, 1982	Substantially Equivalent	RESPIRONICS, INC.
K813064	TELEMETRY TRANSMITTER & RECEIVER	Dec 29, 1981	Substantially Equivalent	HONEYWELL, INC.
K810331	DUO-TEL	Mar 20, 1981	Substantially Equivalent	GENERAL ELECTRIC CO.
K802357	TELEMETRY PACEMAKER MONITOR	Feb 12, 1981	Substantially Equivalent	INTERMEDICS, INC.
K803229	4-CHANNEL ECG TELEMETRY MON. SYST. #3045	Jan 13, 1981	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K802849	TECNOL TELEMETRY UNIT POUCH	Dec 16, 1980	Substantially Equivalent	TECNOL NEW JERSEY WOUND CARE, INC.
K801944	MULTICHANNEL TELEMETRY SYSTEM	Oct 23, 1980	Substantially Equivalent	BURDICK CORP.
K802273	TELEMETRY TRANSMITTER, #TLT-3	Oct 03, 1980	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K791363	KWIK-AWA VEST	Aug 03, 1979	Substantially Equivalent	MEDICAL SPECIALTIES, INC.
K790109	TELEMETRY, BIOMEDICAL	Mar 16, 1979	Substantially Equivalent	LKC TECHNOLOGIES, INC.
K790144	TELEMETRY SYSTEM 315	Feb 23, 1979	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K781836	TELEMETRY SYSTEM, BIOTEL 300	Dec 04, 1978	Substantially Equivalent	SPACELABS, INC.
K772000	ECG TELEMETRY SYSTEM	Nov 22, 1977	Substantially Equivalent	MENNEN GREATBATCH ELECTONICS

FEI Numbers

This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.

1000114185: 228 registrations

1000138054: 760 registrations

1000139754: 47 registrations

1000305720: 78 registrations

1000306431: 841 registrations

1000403400: 19 registrations

1000548922: 11 registrations

1033601: 3 registrations

1218950: 64 registrations

1523530: 22 registrations

1527715: 11 registrations

1713468: 54 registrations

1721686: 241 registrations

1930027: 40 registrations

2024168: 107 registrations

2080783: 62 registrations

2110898: 169 registrations

2124215: 406 registrations

2183613: 23 registrations

2221819: 65 registrations

3000126629: 658 registrations

3000717902: 111 registrations

3001084824: 32 registrations

3001236763: 19 registrations

3001451571: 304 registrations

3002095335: 124 registrations

3002287318: 97 registrations

3002737156: 19 registrations

3002806783: 51 registrations

3002807111: 309 registrations

3002807167: 118 registrations

3002807720: 63 registrations

3002807739: 45 registrations

3003263092: 14 registrations

3003832357: 8 registrations

3003971136: 58 registrations

3003982635: 7 registrations

3004091615: 114 registrations

3004111573: 356 registrations

3004145393: 98 registrations

3004485927: 30 registrations

3004727197: 29 registrations

3004748528: 119 registrations

3005334138: 201 registrations

3005438755: 4 registrations

3006240053: 4 registrations

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