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 |
| K223073 | Alio, Inc. | Alio | 03/17/2023 |
| 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 |
| K081499 | BIOCOMFORT DIAGNOSTICS GMBH & CO. KG | HEALTH MANAGER, VERSION 1.1 | 01/16/2009 |
| K191614 | BioIntelliSense Inc. | BioSticker System | 12/18/2019 |
| K212957 | BiolntelliSense Inc. | BioButton System | 12/12/2022 |
| 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 |
| K191331 | BraveHeart Wireless, Inc. | Life Sensor Cardiac Monitor | 06/12/2019 |
| K002514 | CADUCEUS HEALTH CARE LTD. | CADHEALTH SYSTEM, MODEL CHP-001 | 05/31/2001 |
| K122285 | CARDIOCOM LLC | TABLET COMMANDER | 08/14/2012 |
| K150289 | CARDIOLINE S.p.A | CARDIOLINE HD+ | 08/27/2015 |
| K220526 | Cardioline S.P.A | HD+12, HD+15 | 05/15/2023 |
| 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 |
| K181196 | Caretaker Medical, LLC | Caretaker Remote Display App and Caretaker Software Library | 10/03/2018 |
| 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 |
| K181248 | Comarch Healthcare SA | Comarch e-Care Platform | 10/22/2018 |
| 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 |
| K091430 | DIGIO2 INTERNATIONAL CO., LTD | CARE PAL, MODEL CPW-10X | 08/21/2009 |
| K211822 | Elastic Care Incorporated | LifePath Remote Patient Monitoring Platform | 02/03/2022 |
| 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 |
| K212883 | ergoline GmbH | ers2 - ergoline Rehabilitation System | 07/15/2022 |
| K090801 | EXPRESS MD SOLUTIONS, LLC | ELECTRONIC HOUSE CALL | 04/08/2009 |
| K013533 | GENERAL DEVICES | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | 01/18/2002 |
| K002089 | GENERAL DEVICES | ROSETTA-LT/ROSETTA-RX | 11/21/2000 |
| K030795 | GMP/COMPANIES, INC. | LIFESYNE SYSTEMS | 08/05/2003 |
| K211365 | Graftworx, Inc. dba Alio | Alio Medical Remote Monitoring System | 03/24/2022 |
| 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 |
| 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 |
| 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 |
| 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 |
| K200690 | LifeSignals, Inc. | LifeSignals ECG Remote Monitoring Patch Platform | 07/15/2020 |
| K202868 | LifeSignals, Inc. | LifeSignals Multi-Parameter Remote Monitoring Platform | 07/21/2021 |
| K171188 | LR Med Inc | Ossler Exam Scope | 06/23/2017 |
| 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 |
| K091696 | MEDICOMP, INC. | SAVI WIRELESS, MODEL PM500 | 10/26/2009 |
| K161916 | MEDICOMP, INC. | TelePatch Cardiac Monitor | 12/21/2016 |
| K040663 | MOLEX, INC. | TELENABLE EMS SYSTEM | 06/30/2004 |
| K182297 | Mortara Instrument Inc | Surveyor S2 | 01/24/2019 |
| 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 |
| K071058 | NIHON KOHDEN AMERICA, INC. | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | 06/29/2007 |
| K102106 | NIHON KOHDEN CORP. | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION | 12/17/2010 |
| 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 |
| K192875 | Philips Medical Systems | Philips Biosensor BX100 | 04/16/2020 |
| 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 |
| 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 |
| K223711 | Sibel Health Inc. | ANNE One | 08/10/2023 |
| K211305 | Sibel Inc. | ANNE One | 09/14/2021 |
| K221530 | Sibel Inc. | ANNE Pediatric | 11/22/2022 |
| K213233 | Sigknow Biomedical Co.,Ltd. | EZYPRO ECG Recorder (Model: UG02) | 06/23/2022 |
| 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 |
| K103796 | TELEMEDCARE PTY LTD | TELEMEDCARE HEALTH MONITOR | 08/03/2011 |
| K050128 | TELEVITAL, INC. | VITALWARE VMS | 05/13/2005 |
| 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 |
| K193343 | VitalConnect, Inc. | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | 04/20/2020 |
| K183078 | VitalConnect, Inc. | VitalConnect Platform, VitalPatch Biosensor | 03/07/2019 |
| K192757 | VitalConnect, Inc. | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor û bag of 20, VitalPatch 7D Biosensor û bag of 20 | 02/06/2020 |
| K190916 | VitalConnect, Inc. | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | 06/07/2019 |
| K170973 | VitalConnect, Inc. | VitalWatch Software User Interface | 06/02/2017 |
| K191620 | Vitls Inc. | Vitls Platform | 06/01/2020 |
| K191870 | VivaLNK, Inc. | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | 01/07/2020 |
| K222398 | Vivify Health, Inc. | Care Team Portal | 02/06/2023 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
