FDA 510(k) Applications for Medical Device Product Code "DRG"
(Transmitters And Receivers, Physiological Signal, Radiofrequency)

FDA 510(k) Number Applicant Device Name Decision Date
K101834 3M COMPANY 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM 09/03/2010
K120704 3M COMPANY 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 05/03/2012
K122333 AFRAME DIGITAL, INC. MOBILECARE MONITOR 11/19/2012
K092635 ALCATEL-LUCENT CANADA INC. ALCATEL-LUCENT TELEHEATH MANAGER 09/10/2009
K993550 AMERICAN TELECARE, INC. AVIVA SYSTEM, MODEL SL1010 01/13/2000
K981533 AMERICAN TELECARE, INC. AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 07/15/1998
K973873 AMERICAN TELECARE, INC. DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 12/29/1997
K030222 AMERICAN TELECARE, INC. NX SYSTEM 08/19/2003
K964554 AMERICAN TELECARE, INC. PERSONAL TELEMEDICINE MODULE 12/17/1996
K130676 ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH AMBIO REMOTE HEALTH MONITORING SYSTEM 07/08/2013
K103643 ASCOT TECHNOLOGIES, INC. ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) 10/06/2011
K802273 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC TELEMETRY TRANSMITTER, #TLT-3 10/03/1980
K081499 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG HEALTH MANAGER, VERSION 1.1 01/16/2009
K101078 BL HEALTHCARE, INC. BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM 05/10/2010
K051470 BL HEALTHCARE, INC. REMOTE CARE MANAGEMENT SYSTEMS (RCMS) 06/08/2005
K113493 BL HEALTHCARE, INC. TCX-I REMOTE CARE MANAGEMENT SYSTEM 12/21/2011
K052608 BL HEALTHCARE, INC. TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) 02/01/2006
K170204 Boston Scientific Corporation FFR Link, FFR Signal Processing Module 03/24/2017
K072008 BRAEMAR, INC. BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER 10/03/2007
K801944 BURDICK CORP. MULTICHANNEL TELEMETRY SYSTEM 10/23/1980
K002514 CADUCEUS HEALTH CARE LTD. CADHEALTH SYSTEM, MODEL CHP-001 05/31/2001
K803229 CAMBRIDGE INSTRUMENTS, INC. 4-CHANNEL ECG TELEMETRY MON. SYST. #3045 01/13/1981
K122285 CARDIOCOM LLC TABLET COMMANDER 08/14/2012
K150289 CARDIOLINE S.p.A CARDIOLINE HD+ 08/27/2015
K110809 CAREFUSION 303, INC. WIRELESS MONITORING SYSTEM 07/05/2011
K073038 CAREMATIX INC. CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B 01/11/2008
K100508 CAREMATIX INC. CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B 05/05/2010
K040966 CAREMATIX INC. MODIFICATION TO CAREMATIX WELLNESS SYSTEM 06/02/2004
K134004 CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE 02/14/2014
K122458 CELLO PARTNERSHIP D/B/A VERIZON WIRELESS VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM 07/30/2013
K093134 CERNER CORP. CERNER CAREAWARE IBUS 11/27/2009
K062215 CONFIDANT INC. CONFIDANT 2.0 10/16/2006
K072698 CONFIDANT INC. CONFIDANT 2.5 11/16/2007
K083331 CONFIDANT INC. CONFIDANT, MODEL 2.6 01/09/2009
K120941 CONSTANT CARE, LLC CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM 07/03/2012
K130360 CONSTANT CARE, LLC CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION 07/15/2013
K093895 CONTINUITY HEALTH SOLUTIONS ALLY PLATFORM SYSTEM 05/20/2010
K000276 CRITICARE SYSTEMS, INC. MPT 24 AND VITAL VIEW 24 03/01/2000
K910620 DATEX DIVISION INSTRUMENTARIUM CORP. CARDIOCAP DR-124 RECORDER 05/07/1991
K091430 DIGIO2 INTERNATIONAL CO., LTD CARE PAL, MODEL CPW-10X 08/21/2009
K880036 E.B.S., INC. BIOMA 5000 03/07/1988
K120253 ELCAM MEDICAL A.C.A.L. ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) 07/16/2012
K122095 Emergo Europe Consulting BV ICP TRIAGEMANAGER 07/26/2012
K132930 ENTRA HEALTH SYSTEMS MYHEALTHPOINT TELEHEALTH MANAGER 04/14/2014
K090801 EXPRESS MD SOLUTIONS, LLC ELECTRONIC HOUSE CALL 04/08/2009
K790144 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES TELEMETRY SYSTEM 315 02/23/1979
K013533 GENERAL DEVICES EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) 01/18/2002
K914889 GENERAL DEVICES GEMSCOM SERIES 3000 03/04/1992
K935839 GENERAL DEVICES GEMSCOM SERIES 5000, 11/10/1994
K940009 GENERAL DEVICES GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 04/14/1995
K002089 GENERAL DEVICES ROSETTA-LT/ROSETTA-RX 11/21/2000
K810331 GENERAL ELECTRIC CO. DUO-TEL 03/20/1981
K030795 GMP/COMPANIES, INC. LIFESYNE SYSTEMS 08/05/2003
K050567 HEALTH HERO NETWORK, INC. HEALTH BUDDY APPLIANCE 04/05/2005
K063612 HEALTH HERO NETWORK, INC. MODIFICATION TO HEALTH BUDDY APPLIANCE 12/29/2006
K070543 HEALTH HERO NETWORK, INC. MODIFICATION TO HEALTH BUDDY APPLIANCE 03/28/2007
K080091 HEALTH HERO NETWORK, INC. MODIFICATION TO:HEALTH BUDDY APPLIANCE 02/05/2008
K091220 HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY HEALTHANYWHERE SYSTEM 09/21/2009
K133252 HEALTHINTERLINK, LLC HEALTHINTERLINK BEACON 03/14/2014
K844376 HEWLETT-PACKARD CO. MODEL 78210A TELEMETRY TRANSMITTER 01/10/1985
K993169 HEWLETT-PACKARD CO. MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A 12/20/1999
K172011 HMicro, Inc. LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) 06/14/2018
K141792 HONEYWELL HOMMED GENESIS TOUCH SYSTEM 11/25/2014
K101242 HONEYWELL HOMMED, LLC GENESIS DM MODEL: 6053000A1 06/11/2010
K061087 HONEYWELL HOMMED, LLC GENESIS OTC MONITOR 06/09/2006
K112858 HONEYWELL HOMMED, LLC GENESIS TOUCH SYSTEM 01/24/2012
K153719 HONEYWELL HOMMED, LLC LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream 06/03/2016
K061088 HONEYWELL HOMMED, LLC SENTRY OTC MONITOR 06/09/2006
K813064 HONEYWELL, INC. TELEMETRY TRANSMITTER & RECEIVER 12/29/1981
K090610 HOSPIRA, INC. HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM 03/13/2009
K091021 IMETRIKUS, INC. MODIFICATION TO MEDICOMPASS CONNECT 07/15/2009
K080798 INTEL CORP. INTEL HEALTH GUIDE, MODEL: PHS6000 06/27/2008
K101178 INTEL CORP. MODIFICATION TO INTEL HEALTH GUIDE PHS6000 06/29/2010
K083115 INTEL CORP. MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 11/26/2008
K103276 INTEL CORPORATION DIGITAL HEALTH GROUP INTEL HEALTH GUIDE 02/08/2011
K130821 INTEL-GE CARE INNOVATIONS LLC INTEL-GE CARE INNOVATIONS CONNECT RCM 08/09/2013
K130290 INTEL-GE CARE INNOVATIONS LLC MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE 06/04/2013
K063484 INTERMED ADVISORS, INC. PATIENT DATA HANDLER & DEVICES (PDH&D) 12/22/2006
K802357 INTERMEDICS, INC. TELEMETRY PACEMAKER MONITOR 02/12/1981
K120895 INTOUCH HEALTH, INC. REMOTE PRESENCE SYSTEM 05/24/2012
K123229 INTOUCH HEALTH, INC. REMOTE PRESENCE SYSTEM, MODEL RP-VITA 11/20/2012
K073710 INTOUCH TECHNOLOGIES INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 04/11/2008
K172329 Isansys Lifecare Ltd Patient Status Engine 04/23/2018
K133997 LG ELECTRONICS LG SMARTHEALTH 11/21/2014
K103214 LIFELINE SYSTEMS, INC. M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 12/01/2010
K790109 LKC TECHNOLOGIES, INC. TELEMETRY, BIOMEDICAL 03/16/1979
K171188 LR Med Inc Ossler Exam Scope 06/23/2017
K891104 MARQUETTE ELECTRONICS, INC. CD TELEMETRY SYSTEMS 04/19/1989
K832817 MARQUETTE ELECTRONICS, INC. TELEMETRY SYS SERIES 7700 ECG 01/10/1984
K173510 MC10 Inc. BioStamp nPoint 05/08/2018
K124000 MEDAPPS INC., DBA ALERE CONNECT MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM 07/30/2013
K132803 MEDAPPS INC., DBA ALERE CONNECT MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK 12/12/2013
K083862 MEDAPPS, INC. MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM 06/05/2009
K112559 MEDAPPS, INC. MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM 12/02/2011
K061502 MEDIC4ALL (ISRAEL) LTD. MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 09/15/2006
K062127 MEDIC4ALL (ISRAEL) LTD. MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) 11/08/2006
K062662 MEDIC4ALL (ISRAEL) LTD. TELEMEDICINE SYSTEM MODEL VMS-01 11/21/2006
K061606 MEDICAL DEVICES/PADPRO, INC. DEFIBRILLATOR CABLE TESTER, MODEL DT2200 06/21/2006
K791363 MEDICAL SPECIALTIES, INC. "KWIK-AWA" VEST 08/03/1979
K091696 MEDICOMP, INC. SAVI WIRELESS, MODEL PM500 10/26/2009
K161916 MEDICOMP, INC. TelePatch Cardiac Monitor 12/21/2016
K772000 MENNEN GREATBATCH ELECTONICS ECG TELEMETRY SYSTEM 11/22/1977
K040663 MOLEX, INC. TELENABLE EMS SYSTEM 06/30/2004
K974149 MORTARA INSTRUMENT, INC. AMBULATORY X-12 TELEMETRY MODULE 01/08/1998
K141020 MORTARA INSTRUMENT, INC. SURVEYOR S4 MOBILE MONITOR 12/03/2014
K022274 NEPTEC DESIGN GROUP, LTD. CARECOMPANION PATIENT STATION & NURSE STATION 05/29/2003
K823249 NIHON KOHDEN AMERICA, INC. LIFESCOPE II/FOUR 11/24/1982
K071058 NIHON KOHDEN AMERICA, INC. MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A 06/29/2007
K945578 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER 11/14/1995
K946175 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER 11/22/1995
K860239 NIHON KOHDEN AMERICA, INC. ORG-7201 MULTIPARAMETER TELEMETRY MONITOR 06/26/1986
K102106 NIHON KOHDEN CORP. NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION 12/17/2010
K873672 NOVAMETRIX MEDICAL SYSTEMS, INC. MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR 12/03/1987
K130971 OPTUMHEALTH CARE SOLUTIONS, INC. OPTUM TELEHEALTH APPLICATION 10/23/2013
K050929 PALAISTRA SYSTEMS INC. THE HERMES SYSTEM 05/20/2005
K071564 PHILIPS MEDICAL SYSTEMS MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 08/31/2007
K023749 PHILIPS MEDICAL SYSTEMS THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) 11/19/2002
K052961 PHILIPS MEDICAL SYSTEMS THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN 11/18/2005
K131913 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC 11/26/2013
K100524 POLYMAP WIRELESS, LLC POLYTEL(R) APT MODEL: PWA-08-01 05/24/2010
K934711 PROTOCOL SYSTEMS, INC. PROPAQ ECG TELEMETRY OPTION 09/01/1994
K851302 QUINTON, INC. QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR 05/15/1985
K850166 R.J. ASH, MEDICAL MONITORING, INC. TELEMANOMETER 04/18/1985
K821384 RESPIRONICS, INC. EXERCISE ECG ELECTRODES, REUSABLE 06/17/1982
K163694 Rooti Labs Ltd. Rooti Rx ECG Event Recorder, Rooti Link APP Software 11/07/2017
K062304 RTX HEALTHCARE A/S DLM112 DAYLINK MONITOR 09/29/2006
K041816 RTX HEALTHCARE A/S RTX3320PSTN WIRELESS TELEHEALTH GATEWAY 07/19/2004
K071953 RTX HEALTHCARE A/S RTX3370 08/08/2007
K132148 SAMSUNG ELECTRONICS CO., LTD. S HEALTH 12/04/2013
K132173 SANITAS, INC. FAMILY HEALTHWARE 05/30/2014
K123671 SANITAS, INC. WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM 01/16/2013
K050778 SCOTTCARE TELEREHAD 2004 04/13/2005
K945037 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS 1481 T TRANSMITTER, ENHANCED 03/21/1995
K113402 SOLOHEALTH, INC. SOLOHEALTH STATION 05/30/2012
K781836 SPACELABS, INC. TELEMETRY SYSTEM, BIOTEL 300 12/04/1978
K111854 ST. JUDE MEDICAL SYSTEMS AB AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER 10/21/2011
K133587 ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 12/20/2013
K171019 Synergen Technology Labs LLC ScioCardio ECG Transmitter 05/30/2018
K100427 TaiDoc Technology Corporation FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY 05/28/2010
K083046 TaiDoc Technology Corporation FORA TELEHEALTH SYSTEM 01/16/2009
K802849 TECNOL NEW JERSEY WOUND CARE, INC. TECNOL TELEMETRY UNIT POUCH 12/16/1980
K103796 TELEMEDCARE PTY LTD TELEMEDCARE HEALTH MONITOR 08/03/2011
K050128 TELEVITAL, INC. VITALWARE VMS 05/13/2005
K823906 TRANSKINETIC SYSTEMS, INC. TELEMETRY SYSTEM 03/09/1983
K904748 TRANSTRACHEAL SYSTEMS TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 03/01/1991
K090886 TUNSTALL HEALTHCARE RTX 3371 04/15/2009
K171406 United Health Group Inc. Optum TeleHealth Application 08/18/2017
K113446 VIGNET INC. VIGNET TELEHEALTH MANAGER 07/16/2012
K171029 Visicu Inc. eCareCoordinator 07/14/2017
K141706 VISICU, INC. ECARE COORDINATOR (ECC) 09/09/2014
K141167 VITAL CONNECT INC. VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) 07/29/2014
K132447 Vital Connect, Inc VITALCONNECT PLATFORM BY VITAL CONNECT INC. 04/03/2014
K152139 VITAL CONNECT, INC. Vital Connect Platform, HealthPatch MD, VitalPatch 12/06/2015
K163453 VITAL CONNECT, INC. VitalPatch« VitalConnect Platform 11/02/2017
K170973 VitalConnect, Inc. VitalWatch Software User Interface 06/02/2017
K111922 VOCARE, INC VOCARE MYHEALTH TABLET 12/02/2011
K110334 WALDO HEALTH WALDO PATIENT MONITOR 04/12/2011
K120325 WATERMARK MEDICAL CONNECTED CARE MOBILE APPLICATION 07/18/2012
K120470 WATERMARK MEDICAL MIPAL 06/08/2012
K122763 ZEPHYR TECHNOLOGY CORPORATION PHYSIOLOGICAL DATA PROCESSOR 06/20/2013


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