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
49–72 of 192
Cleared Dec 03, 2014
SURVEYOR S4 MOBILE MONITOR
K141020
Mortara Instrument, Inc.
Cardiovascular · 226d
Cleared Nov 25, 2014
GENESIS TOUCH SYSTEM
K141792
Honeywell Hommed
Cardiovascular · 146d
Cleared Nov 21, 2014
LG SMARTHEALTH
K133997
Lg Electronics
Cardiovascular · 329d
Cleared Sep 09, 2014
ECARE COORDINATOR (ECC)
K141706
Visicu, Inc.
Cardiovascular · 77d
Cleared Jul 29, 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
K141167
Vitalconnect, Inc.
Cardiovascular · 84d
Cleared May 30, 2014
FAMILY HEALTHWARE
K132173
Sanitas, Inc.
Cardiovascular · 319d
Cleared Apr 14, 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930
Entra Health Systems
Cardiovascular · 208d
Cleared Apr 03, 2014
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
K132447
Vitalconnect, Inc.
Cardiovascular · 240d
Cleared Mar 14, 2014
HEALTHINTERLINK BEACON
K133252
Healthinterlink, LLC
Cardiovascular · 143d
Cleared Feb 14, 2014
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
K134004
Cellco Partnership D/B/A Verizon Wireless
Cardiovascular · 49d
Cleared Dec 20, 2013
PRESSUREWIRE AERIS AGILE TIP
K133587
St. Jude Medical Systems AB
Cardiovascular · 29d
Cleared Dec 12, 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803
Medapps Inc., Dba Alere Connect
Cardiovascular · 97d
Cleared Dec 04, 2013
S HEALTH
K132148
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Nov 26, 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
K131913
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 153d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Aug 09, 2013
INTEL-GE CARE INNOVATIONS CONNECT RCM
K130821
Intel-Ge Care Innovations, LLC
Cardiovascular · 137d
Cleared Jul 30, 2013
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
K122458
Cello Partnership D/B/A Verizon Wireless
Cardiovascular · 351d
Cleared Jul 30, 2013
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
K124000
Medapps Inc., Dba Alere Connect
Cardiovascular · 216d
Cleared Jul 15, 2013
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
K130360
Constant Care, LLC
Cardiovascular · 152d
Cleared Jul 08, 2013
AMBIO REMOTE HEALTH MONITORING SYSTEM
K130676
Arrayent Health, LLC D/B/A Ambio Health
Cardiovascular · 118d
Cleared Jun 20, 2013
PHYSIOLOGICAL DATA PROCESSOR
K122763
Zephyr Technology Corporation
Cardiovascular · 283d
Cleared Jun 04, 2013
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
K130290
Intel-Ge Care Innovations, LLC
Cardiovascular · 118d
Cleared Jan 16, 2013
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
K123671
Sanitas, Inc.
Cardiovascular · 48d
Cleared Nov 20, 2012
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229
Intouch Health, Inc.
Cardiovascular · 36d