DRG · Class II · 21 CFR 870.2910

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

Leading manufacturers include Nihon Kohden America, Inc., Vitalconnect, Inc. and Philips Medical Systems.

192
Total
192
Cleared
127d
Avg days
1977
Since
192 devices
25–48 of 192
Cleared Jan 07, 2020
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
K191870
VivaLNK, Inc.
Cardiovascular · 179d
Cleared Dec 18, 2019
BioSticker System
K191614
Biointellisense, Inc.
Cardiovascular · 183d
Cleared Jun 12, 2019
Life Sensor Cardiac Monitor
K191331
Braveheart Wireless, Inc.
Cardiovascular · 27d
Cleared Jun 07, 2019
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
K190916
Vitalconnect, Inc.
Cardiovascular · 59d
Cleared Mar 07, 2019
VitalConnect Platform, VitalPatch Biosensor
K183078
Vitalconnect, Inc.
Cardiovascular · 122d
Cleared Jan 24, 2019
Surveyor S2
K182297
Mortara Instrument, Inc.
Cardiovascular · 153d
Cleared Oct 22, 2018
Comarch e-Care Platform
K181248
Comarch Healthcare SA
Cardiovascular · 165d
Cleared Oct 03, 2018
Caretaker Remote Display App and Caretaker Software Library
K181196
Caretaker Medical, LLC
Cardiovascular · 149d
Cleared Jun 14, 2018
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
K172011
Hmicro, Inc.
Cardiovascular · 346d
Cleared May 30, 2018
ScioCardio ECG Transmitter
K171019
Synergen Technology Labs, LLC
Cardiovascular · 420d
Cleared May 08, 2018
BioStamp nPoint
K173510
Mc10, Inc.
Cardiovascular · 176d
Cleared Apr 23, 2018
Patient Status Engine
K172329
Isansys Lifecare, Ltd.
Cardiovascular · 264d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Dec 03, 2014
SURVEYOR S4 MOBILE MONITOR
K141020
Mortara Instrument, Inc.
Cardiovascular · 226d
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 May 03, 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704
3M Company
Cardiovascular · 56d
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 Mar 13, 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610
Hospira, Inc.
Cardiovascular · 7d
Cleared Jan 16, 2009
FORA TELEHEALTH SYSTEM
K083046
Taidoc Technology Corporation
Cardiovascular · 94d
Cleared Aug 31, 2007
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
K071564
Philips Medical Systems
Cardiovascular · 85d
Cleared Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058
Nihon Kohden America, Inc.
Cardiovascular · 74d
Cleared Nov 18, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
K052961
Philips Medical Systems
Cardiovascular · 28d