DRG · Class II · 21 CFR 870.2910

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

Leading manufacturers include Vitalconnect, Inc., Lifesignals, Inc. and 3M Company.

191
Total
191
Cleared
127d
Avg days
1977
Since
191 devices
25–48 of 191
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 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 Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Mar 21, 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037
Siemens Medical Solutions USA, Inc.
Cardiovascular · 159d
Cleared Jan 10, 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376
Hewlett-Packard Co.
Cardiovascular · 58d
Cleared Mar 20, 1981
DUO-TEL
K810331
General Electric Co.
Cardiovascular · 39d
Cleared Feb 12, 1981
TELEMETRY PACEMAKER MONITOR
K802357
Intermedics, Inc.
Cardiovascular · 139d
Cleared Oct 03, 1980
TELEMETRY TRANSMITTER, #TLT-3
K802273
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 16d