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 |
|---|---|---|---|
| Nov 21, 2014 | K133997 | LG SMARTHEALTH Lg Electronics | DRG |
| Sep 9, 2014 | K141706 | ECARE COORDINATOR (ECC) Visicu, Inc. | DRG |
| Jul 29, 2014 | K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) Vitalconnect, Inc. | DRG |
| May 30, 2014 | K132173 | FAMILY HEALTHWARE Sanitas, Inc. | DRG |
| Apr 14, 2014 | K132930 | MYHEALTHPOINT TELEHEALTH MANAGER Entra Health Systems | DRG |
| Apr 3, 2014 | K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC. Vitalconnect, Inc. | DRG |
| Mar 14, 2014 | K133252 | HEALTHINTERLINK BEACON Healthinterlink, LLC | DRG |
| Feb 14, 2014 | K134004 | VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE Cellco Partnership D/B/A Verizon Wireless | DRG |
| Dec 20, 2013 | K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 St. Jude Medical Systems AB | DRG |
| Dec 12, 2013 | K132803 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK Medapps Inc., Dba Alere Connect | DRG |
| Dec 4, 2013 | K132148 | S HEALTH Samsung Electronics Co., Ltd., KR | DRG |
| Nov 26, 2013 | K131913 | INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC Philips Medizin Systeme Boeblingen GmbH, DE | DRG |
| Oct 23, 2013 | K130971 | OPTUM TELEHEALTH APPLICATION Optumhealth Care Solutions, Inc., CA | DRG |
| Aug 9, 2013 | K130821 | INTEL-GE CARE INNOVATIONS CONNECT RCM Intel-Ge Care Innovations, LLC | DRG |
| Jul 30, 2013 | K124000 | MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM Medapps Inc., Dba Alere Connect | DRG |
| Jul 30, 2013 | K122458 | VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM Cello Partnership D/B/A Verizon Wireless | DRG |
| Jul 15, 2013 | K130360 | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION Constant Care, LLC | DRG |
| Jul 8, 2013 | K130676 | AMBIO REMOTE HEALTH MONITORING SYSTEM Arrayent Health, LLC D/B/A Ambio Health | DRG |
| Jun 20, 2013 | K122763 | PHYSIOLOGICAL DATA PROCESSOR Zephyr Technology Corporation | DRG |
| Jun 4, 2013 | K130290 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE Intel-Ge Care Innovations, LLC | DRG |
| Jan 16, 2013 | K123671 | WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM Sanitas, Inc. | DRG |
| Nov 20, 2012 | K123229 | REMOTE PRESENCE SYSTEM, MODEL RP-VITA Intouch Health, Inc. | DRG |
| Nov 19, 2012 | K122333 | MOBILECARE MONITOR Aframe Digital, Inc. | DRG |
| Aug 14, 2012 | K122285 | TABLET COMMANDER Cardiocom, LLC | DRG |
| Jul 26, 2012 | K122095 | ICP TRIAGEMANAGER Emergo Europe Consulting BV, NL | DRG |
| Jul 18, 2012 | K120325 | CONNECTED CARE MOBILE APPLICATION Watermark Medical | DRG |
| Jul 16, 2012 | K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) Elcam Medical Acal, IL | DRG |
| Jul 16, 2012 | K113446 | VIGNET TELEHEALTH MANAGER Vignet, Inc. | DRG |
| Jul 3, 2012 | K120941 | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM Constant Care, LLC | DRG |
| Jun 8, 2012 | K120470 | MIPAL Watermark Medical | DRG |
| May 24, 2012 | K120895 | REMOTE PRESENCE SYSTEM Intouch Health, Inc. | DRG |
| May 3, 2012 | K120704 | 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 3M Company | DRG |
| Jan 24, 2012 | K112858 | GENESIS TOUCH SYSTEM Honeywell Hommed, LLC | DRG |
| Dec 21, 2011 | K113493 | TCX-I REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. | DRG |
| Dec 2, 2011 | K112559 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM Medapps, Inc. | DRG |
| Dec 2, 2011 | K111922 | VOCARE MYHEALTH TABLET Vocare, Inc. | DRG |
| Oct 21, 2011 | K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER St. Jude Medical Systems AB, SE | DRG |
| Oct 6, 2011 | K103643 | ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) Ascot Technologies, Inc. | DRG |
| Aug 3, 2011 | K103796 | TELEMEDCARE HEALTH MONITOR Telemedcare Pty, Ltd., AU | DRG |
| Jul 5, 2011 | K110809 | WIRELESS MONITORING SYSTEM Carefusion 303, Inc., GB | DRG |
| Apr 12, 2011 | K110334 | WALDO PATIENT MONITOR Waldo Health | DRG |
| Feb 8, 2011 | K103276 | INTEL HEALTH GUIDE Intel Corporation Digital Health Group | DRG |
| Dec 17, 2010 | K102106 | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION Nihon Kohden Corp. | DRG |
| Dec 1, 2010 | K103214 | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 Lifeline Systems, Inc. | DRG |
| Sep 3, 2010 | K101834 | 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM 3M Company | DRG |
| Jun 29, 2010 | K101178 | MODIFICATION TO INTEL HEALTH GUIDE PHS6000 Intel Corp. | DRG |
| Jun 11, 2010 | K101242 | GENESIS DM MODEL: 6053000A1 Honeywell Hommed, LLC | DRG |
| May 28, 2010 | K100427 | FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY Taidoc Technology Corporation, TW | DRG |
| May 24, 2010 | K100524 | POLYTEL(R) APT MODEL: PWA-08-01 Polymap Wireless, LLC | DRG |
| May 20, 2010 | K093895 | ALLY PLATFORM SYSTEM Continuity Health Solutions | DRG |
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