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
25–48 of 192
Cleared Feb 06, 2020
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
K192757
Vitalconnect, Inc.
Cardiovascular · 129d
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 Nov 07, 2017
Rooti Rx ECG Event Recorder, Rooti Link APP Software
K163694
Rooti Labs , Ltd.
Cardiovascular · 314d
Cleared Nov 02, 2017
VitalPatch® VitalConnect Platform
K163453
Vitalconnect, Inc.
Cardiovascular · 328d
Cleared Aug 18, 2017
Optum TeleHealth Application
K171406
United Health Group, Inc.
Cardiovascular · 98d
Cleared Jul 14, 2017
eCareCoordinator
K171029
Visicu, Inc.
Cardiovascular · 99d
Cleared Jun 23, 2017
Ossler Exam Scope
K171188
Lr Med, Inc.
Cardiovascular · 60d
Cleared Jun 02, 2017
VitalWatch Software User Interface
K170973
Vitalconnect, Inc.
Cardiovascular · 60d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Dec 21, 2016
TelePatch Cardiac Monitor
K161916
Medicomp, Inc.
Cardiovascular · 162d
Cleared Jun 03, 2016
LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
K153719
Honeywell Hommed, LLC
Cardiovascular · 158d
Cleared Dec 06, 2015
Vital Connect Platform, HealthPatch MD, VitalPatch
K152139
Vitalconnect, Inc.
Cardiovascular · 125d
Cleared Aug 27, 2015
CARDIOLINE HD+
K150289
Cardioline S.P.A
Cardiovascular · 203d