DRG · Class II · 21 CFR 870.2910

FDA Product Code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Leading manufacturers include Vitalconnect, Inc., Nihon Kohden America, Inc. and American Telecare, Inc..

192
Total
192
Cleared
127d
Avg days
1977
Since
192 devices
73–96 of 192
Cleared Nov 19, 2012
MOBILECARE MONITOR
K122333
Aframe Digital, Inc.
Cardiovascular · 109d
Cleared Aug 14, 2012
TABLET COMMANDER
K122285
Cardiocom, LLC
Cardiovascular · 15d
Cleared Jul 26, 2012
ICP TRIAGEMANAGER
K122095
Emergo Europe Consulting BV
Cardiovascular · 14d
Cleared Jul 18, 2012
CONNECTED CARE MOBILE APPLICATION
K120325
Watermark Medical
Cardiovascular · 167d
Cleared Jul 16, 2012
VIGNET TELEHEALTH MANAGER
K113446
Vignet, Inc.
Cardiovascular · 238d
Cleared Jul 16, 2012
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253
Elcam Medical Acal
Cardiovascular · 171d
Cleared Jul 03, 2012
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
K120941
Constant Care, LLC
Cardiovascular · 96d
Cleared Jun 08, 2012
MIPAL
K120470
Watermark Medical
Cardiovascular · 113d
Cleared May 24, 2012
REMOTE PRESENCE SYSTEM
K120895
Intouch Health, Inc.
Cardiovascular · 62d
Cleared May 03, 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704
3M Company
Cardiovascular · 56d
Cleared Jan 24, 2012
GENESIS TOUCH SYSTEM
K112858
Honeywell Hommed, LLC
Cardiovascular · 116d
Cleared Dec 21, 2011
TCX-I REMOTE CARE MANAGEMENT SYSTEM
K113493
Bl Healthcare, Inc.
Cardiovascular · 26d
Cleared Dec 02, 2011
VOCARE MYHEALTH TABLET
K111922
Vocare, Inc.
Cardiovascular · 149d
Cleared Dec 02, 2011
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K112559
Medapps, Inc.
Cardiovascular · 91d
Cleared Oct 21, 2011
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
K111854
St. Jude Medical Systems AB
Cardiovascular · 114d
Cleared Oct 06, 2011
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
K103643
Ascot Technologies, Inc.
Cardiovascular · 297d
Cleared Aug 03, 2011
TELEMEDCARE HEALTH MONITOR
K103796
Telemedcare Pty, Ltd.
Cardiovascular · 219d
Cleared Jul 05, 2011
WIRELESS MONITORING SYSTEM
K110809
Carefusion 303, Inc.
Cardiovascular · 104d
Cleared Apr 12, 2011
WALDO PATIENT MONITOR
K110334
Waldo Health
Cardiovascular · 67d
Cleared Feb 08, 2011
INTEL HEALTH GUIDE
K103276
Intel Corporation Digital Health Group
Cardiovascular · 95d
Cleared Sep 03, 2010
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
K101834
3M Company
Cardiovascular · 64d
Cleared May 28, 2010
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
K100427
Taidoc Technology Corporation
Cardiovascular · 101d
Cleared Oct 26, 2009
SAVI WIRELESS, MODEL PM500
K091696
Medicomp, Inc.
Cardiovascular · 138d
Cleared Mar 13, 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610
Hospira, Inc.
Cardiovascular · 7d