DSH · Class II · 21 CFR 870.2800

FDA Product Code DSH: Recorder, Magnetic Tape, Medical

Leading manufacturers include Del Mar Avionics, Bardy Diagnostics, Inc. and Oxford Medilog, Inc..

195
Total
195
Cleared
125d
Avg days
1976
Since
195 devices
25–48 of 195
Cleared Jul 29, 2020
Bioflux Software II
K201040
Biotricity
Cardiovascular · 119d
Cleared May 01, 2020
Carnation Ambulatory Monitor
K200870
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Oct 17, 2019
Carnation Ambulatory Monitor
K192556
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Aug 30, 2019
Carnation Ambulatory Monitor
K191471
Bardy Diagnostics, Inc.
Cardiovascular · 88d
Cleared May 16, 2019
Carnation Ambulatory Monitor
K191000
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Aug 03, 2018
ECG recorder and Arrhythmia Detector
K173461
Smart Solutions Technologies SL
Cardiovascular · 269d
Cleared Jul 24, 2018
Portable ECG Monitor (ECG3)
K172862
Andon Health Co, Ltd.
Cardiovascular · 307d
Cleared Jan 04, 2018
ePatch
K171410
Braemar Manufacturing, LLC
Cardiovascular · 234d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Mar 24, 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
K162503
Cardiac Insight, Inc.
Cardiovascular · 198d
Cleared Feb 22, 2017
my Patch sl
K163535
Dms-Service, LLC
Cardiovascular · 68d
Cleared Oct 13, 2016
Bioflux Software
K162571
Biotricity, Inc.
Cardiovascular · 28d
Cleared Jul 15, 2016
myPatch-s
K160704
Dms-Service, LLC
Cardiovascular · 123d
Cleared Jul 11, 2015
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
K142468
Cardiac Insight, Inc.
Cardiovascular · 311d
Cleared Jun 19, 2015
ZIO SR ECG Monitoring Service
K143513
iRhythm Technologies, Inc.
Cardiovascular · 190d
Cleared Dec 22, 2014
Carnation Ambulatory Monitor
K143067
Bardy Diagnostics, Inc.
Cardiovascular · 59d
Cleared Oct 29, 2013
MYPATCH
K131190
Dms-Service, LLC
Cardiovascular · 186d
Cleared May 29, 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
K130288
Cardiac Insight, Inc.
Cardiovascular · 113d
Cleared Jul 18, 2012
ZIO PATCH
K121319
iRhythm Technologies, Inc.
Cardiovascular · 77d
Cleared Feb 06, 2012
ZIO PATCH
K113862
iRhythm Technologies, Inc.
Cardiovascular · 38d
Cleared Dec 21, 2011
MYSENSE HEART
K113176
Cardiac Science Corporation
Cardiovascular · 54d
Cleared Nov 23, 2011
VITALOGRAPH MODEL 7100 - VITALOJAK
K110525
Vitalograph (Ireland) , Ltd.
Cardiovascular · 273d
Cleared Oct 07, 2011
GLOBALCARDIO
K111320
Cardiocomm Solutions, Inc.
Cardiovascular · 150d
Cleared Aug 01, 2011
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
K111745
Card Guard Scientific Survival , Ltd.
Cardiovascular · 41d