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 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 Aug 01, 2011
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
K111745
Card Guard Scientific Survival , Ltd.
Cardiovascular · 41d
Cleared Aug 24, 2005
H12+ HOLTER RECORDER
K050896
Mortara Instrument, Inc.
Cardiovascular · 138d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103
Philips Medical Systems
Cardiovascular · 14d
Cleared Apr 05, 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825
Card Guard Scientific Survival , Ltd.
Cardiovascular · 22d
Cleared Feb 09, 1999
OMNICORDER, MODEL 464
K990027
Del Mar Avionics
Cardiovascular · 35d
Cleared Feb 19, 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174
Del Mar Avionics
Cardiovascular · 211d
Cleared Aug 17, 1995
HOLTER PACERCORDER(R)
K950020
Del Mar Avionics
Cardiovascular · 225d
Cleared Jul 14, 1995
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
K951605
Spacelabs, Inc.
Cardiovascular · 98d
Cleared May 10, 1995
HOLTER SSR DIGICORDER(TM)
K942653
Del Mar Avionics
Cardiovascular · 341d
Cleared Dec 03, 1993
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660
R & D Batteries, Inc.
Cardiovascular · 66d
Cleared Oct 16, 1991
CARD GUARD, MODELS CG-6000 & CG-7000
K910884
Card Guard Scientific Survival , Ltd.
Cardiovascular · 226d
Cleared Oct 04, 1991
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
K913038
Spacelabs, Inc.
Cardiovascular · 87d
Cleared Aug 19, 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257
Mennen Medical, Inc.
Cardiovascular · 151d
Cleared Aug 07, 1991
PR4
K911097
Mortara Instrument, Inc.
Cardiovascular · 148d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793
Del Mar Avionics
Cardiovascular · 138d