DSH · Class II · 21 CFR 870.2800

FDA Product Code DSH: Recorder, Magnetic Tape, Medical

Leading manufacturers include Bardy Diagnostics, Inc., Wellysis Corp. and iRhythm Technologies, Inc..

194
Total
194
Cleared
125d
Avg days
1976
Since
194 devices
25–48 of 194
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 Feb 19, 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Jul 21, 1987
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246
Medtronic Vascular
Cardiovascular · 40d
Cleared Oct 24, 1984
MINGOGRAF 7
K841868
Siemens Medical Solutions USA, Inc.
Cardiovascular · 173d