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 iRhythm Technologies, Inc..

195
Total
195
Cleared
125d
Avg days
1976
Since
195 devices
49–72 of 195
Cleared Jun 28, 2011
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
K111180
Vasomedical, Inc.
Cardiovascular · 62d
Cleared Jun 24, 2011
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
K111096
Vasomedical, Inc.
Cardiovascular · 65d
Cleared Jul 09, 2010
PULMOTRACK 5050 WHOLTER, MODEL 5050
K101022
Karmelsonix
Cardiovascular · 87d
Cleared Apr 02, 2010
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
K092785
Vasomedical, Inc.
Cardiovascular · 204d
Cleared Jun 10, 2009
COR12+
K091505
Viasys Healthcare GmbH
Cardiovascular · 20d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363
iRhythm Technologies, Inc.
Cardiovascular · 84d
Cleared Apr 01, 2009
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
K083820
Vasomedical, Inc.
Cardiovascular · 100d
Cleared Jan 10, 2008
PC-180 / PRINCE 180 EASY ECG MONITOR
K073152
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 63d
Cleared Apr 06, 2007
MEDILOGAR4, MEDILOGAR12
K070818
Tom Medical Entwicklungs GmbH
Cardiovascular · 11d
Cleared Aug 16, 2006
DMS 300-7
K062007
Diagnostic Monitoring Software
Cardiovascular · 30d
Cleared Aug 24, 2005
H12+ HOLTER RECORDER
K050896
Mortara Instrument, Inc.
Cardiovascular · 138d
Cleared Oct 31, 2003
MODIFICATION TO GLOBALCARDIO
K033037
Cardiocomm Solutions, Inc.
Cardiovascular · 32d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103
Philips Medical Systems
Cardiovascular · 14d
Cleared Oct 24, 2002
CARDIO ID+(RZ153+)
K022540
Rozinn Electronics, Inc.
Cardiovascular · 84d
Cleared Sep 27, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K022297
Cardiocomm Solutions, Inc.
Cardiovascular · 73d
Cleared Apr 05, 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825
Card Guard Scientific Survival , Ltd.
Cardiovascular · 22d
Cleared Jan 31, 2002
GLOBALCARDIO
K013354
Cardiocomm Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 25, 2001
DR180+OXY
K004007
North East Monitoring, Inc.
Cardiovascular · 30d
Cleared Apr 19, 2000
LIFECARD CF COMPACT RECORDER
K001025
Reynolds Medical , Ltd.
Cardiovascular · 20d
Cleared Jun 11, 1999
CARDIOLIGHT
K982448
Capintec, Inc.
Cardiovascular · 331d
Cleared Feb 09, 1999
OMNICORDER, MODEL 464
K990027
Del Mar Avionics
Cardiovascular · 35d
Cleared Jan 27, 1999
MERCATOR
K982384
Harley Street Software , Ltd.
Cardiovascular · 203d
Cleared Aug 25, 1998
MICROVIT MT-100
K973735
Schiller America, Inc.
Cardiovascular · 329d
Cleared Feb 19, 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420
Hewlett-Packard Co.
Cardiovascular · 87d