Panels › Cardiovascular › Product code DRG · Class 2
Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation 870.2910
2510(k)s in 12 months (192 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DRG
| Company | 510(k)s | Recalls |
|---|---|---|
| Vitalconnect, Inc. | 9 | 1 |
| Honeywell Hommed | 6 | 0 |
| Nihon Kohden America, Inc. | 5 | 1 |
| American Telecare, Inc. | 5 | 0 |
| General Devices | 5 | 0 |
| Bl Healthcare, Inc. | 4 | 0 |
| Health Hero Network, Inc. | 4 | 0 |
| Lifesignals, Inc. | 4 | 0 |
| Philips Medical Systems | 4 | 0 |
| Biointellisense, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 10, 2010 | K101078 | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. | DRG |
| May 5, 2010 | K100508 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B Carematix, Inc. | DRG |
| Nov 27, 2009 | K093134 | CERNER CAREAWARE IBUS Cerner Corp. | DRG |
| Oct 26, 2009 | K091696 | SAVI WIRELESS, MODEL PM500 Medicomp, Inc. | DRG |
| Sep 21, 2009 | K091220 | HEALTHANYWHERE SYSTEM Healthanywhere, an Igeacare System Company, CA | DRG |
| Sep 10, 2009 | K092635 | ALCATEL-LUCENT TELEHEATH MANAGER Alcatel-Lucent Canada, Inc., CA | DRG |
| Aug 21, 2009 | K091430 | CARE PAL, MODEL CPW-10X Digio2 International Co., Ltd. | DRG |
| Jul 15, 2009 | K091021 | MODIFICATION TO MEDICOMPASS CONNECT Imetrikus, Inc. | DRG |
| Jun 5, 2009 | K083862 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM Medapps, Inc. | DRG |
| Apr 15, 2009 | K090886 | RTX 3371 Tunstall Healthcare, NO | DRG |
| Apr 8, 2009 | K090801 | ELECTRONIC HOUSE CALL Express MD Solutions, LLC | DRG |
| Mar 13, 2009 | K090610 | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM Hospira, Inc. | DRG |
| Jan 16, 2009 | K083046 | FORA TELEHEALTH SYSTEM Taidoc Technology Corporation, TW | DRG |
| Jan 16, 2009 | K081499 | HEALTH MANAGER, VERSION 1.1 Biocomfort Diagnostics GmbH & Co. KG, DE | DRG |
| Jan 9, 2009 | K083331 | CONFIDANT, MODEL 2.6 Confidant, Inc. | DRG |
| Nov 26, 2008 | K083115 | MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 Intel Corp. | DRG |
| Jun 27, 2008 | K080798 | INTEL HEALTH GUIDE, MODEL: PHS6000 Intel Corp. | DRG |
| Apr 11, 2008 | K073710 | INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 Intouch Technologies | DRG |
| Feb 5, 2008 | K080091 | MODIFICATION TO:HEALTH BUDDY APPLIANCE Health Hero Network, Inc. | DRG |
| Jan 11, 2008 | K073038 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B Carematix, Inc. | DRG |
| Nov 16, 2007 | K072698 | CONFIDANT 2.5 Confidant, Inc. | DRG |
| Oct 3, 2007 | K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER Braemar, Inc. | DRG |
| Aug 31, 2007 | K071564 | MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 Philips Medical Systems | DRG |
| Aug 8, 2007 | K071953 | RTX3370 Rtx Healthcare A/S, DK | DRG |
| Jun 29, 2007 | K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A Nihon Kohden America, Inc. | DRG |
| Mar 28, 2007 | K070543 | MODIFICATION TO HEALTH BUDDY APPLIANCE Health Hero Network, Inc. | DRG |
| Dec 29, 2006 | K063612 | MODIFICATION TO HEALTH BUDDY APPLIANCE Health Hero Network, Inc. | DRG |
| Dec 22, 2006 | K063484 | PATIENT DATA HANDLER & DEVICES (PDH&D) Intermed Advisors, Inc. | DRG |
| Nov 21, 2006 | K062662 | TELEMEDICINE SYSTEM MODEL VMS-01 Medic4all (Israel) , Ltd. | DRG |
| Nov 8, 2006 | K062127 | MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) Medic4all (Israel) , Ltd. | DRG |
| Oct 16, 2006 | K062215 | CONFIDANT 2.0 Confidant, Inc. | DRG |
| Sep 29, 2006 | K062304 | DLM112 DAYLINK MONITOR Rtx Healthcare A/S, DK | DRG |
| Sep 15, 2006 | K061502 | MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 Medic4all (Israel) , Ltd. | DRG |
| Jun 21, 2006 | K061606 | DEFIBRILLATOR CABLE TESTER, MODEL DT2200 Medical Devices/Padpro, Inc. | DRG |
| Jun 9, 2006 | K061088 | SENTRY OTC MONITOR Honeywell Hommed, LLC | DRG |
| Jun 9, 2006 | K061087 | GENESIS OTC MONITOR Honeywell Hommed, LLC | DRG |
| Feb 1, 2006 | K052608 | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) Bl Healthcare, Inc. | DRG |
| Nov 18, 2005 | K052961 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN Philips Medical Systems | DRG |
| Jun 8, 2005 | K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) Bl Healthcare, Inc. | DRG |
| May 20, 2005 | K050929 | THE HERMES SYSTEM Palaistra Systems, Inc. | DRG |
| May 13, 2005 | K050128 | VITALWARE VMS Televital, Inc. | DRG |
| Apr 13, 2005 | K050778 | TELEREHAD 2004 Scottcare | DRG |
| Apr 5, 2005 | K050567 | HEALTH BUDDY APPLIANCE Health Hero Network, Inc. | DRG |
| Jul 19, 2004 | K041816 | RTX3320PSTN WIRELESS TELEHEALTH GATEWAY Rtx Healthcare A/S, DK | DRG |
| Jun 30, 2004 | K040663 | TELENABLE EMS SYSTEM Molex, Inc. | DRG |
| Jun 2, 2004 | K040966 | MODIFICATION TO CAREMATIX WELLNESS SYSTEM Carematix, Inc. | DRG |
| Aug 19, 2003 | K030222 | NX SYSTEM American Telecare, Inc. | DRG |
| Aug 5, 2003 | K030795 | LIFESYNE SYSTEMS Gmp/Companies, Inc. | DRG |
| May 29, 2003 | K022274 | CARECOMPANION PATIENT STATION & NURSE STATION Neptec Design Group, Ltd., CA | DRG |
| Nov 19, 2002 | K023749 | THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) Philips Medical Systems | DRG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.