MWJ · Class II · 21 CFR 870.2800

FDA Product Code MWJ: Electrocardiograph, Ambulatory (without Analysis)

Leading manufacturers include North East Monitoring, Inc., Getemed Medizin- Und Informationstechnik AG and Mortara Instrument, Inc..

62
Total
62
Cleared
147d
Avg days
1998
Since
62 devices
25–48 of 62
Cleared Jul 24, 2007
DL900 SERIES HOLTER RECORDER
K071733
Braemar, Inc.
Cardiovascular · 28d
Cleared May 30, 2007
CARDIOMEM CM 3000-12BT
K063042
Getemed Medizin- Und Informationstechnik AG
Cardiovascular · 239d
Cleared May 25, 2007
AUTO DETECT FOR TELAHEART DR200/E-A
K070014
North East Monitoring, Inc.
Cardiovascular · 142d
Cleared Apr 27, 2007
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
K071011
Braemar, Inc.
Cardiovascular · 17d
Cleared Oct 16, 2006
DMS 300-2, 300-3 AND 300-4
K062959
Diagnostic Monitoring Software
Cardiovascular · 17d
Cleared Aug 25, 2006
TELAHEART DIGITAL RECORDER
K061293
North East Monitoring, Inc.
Cardiovascular · 108d
Cleared Jul 14, 2005
CARDIOMEM CM 3000-12
K051686
Getemed Medizin- Und Informationstechnik AG
Cardiovascular · 21d
Cleared May 19, 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731
Ge Medical Systems Information Technologies
Cardiovascular · 59d
Cleared Feb 25, 2005
HOLTER RECORDER H3+
K043010
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Oct 06, 2004
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
K042469
Braemar, Inc.
Cardiovascular · 23d
Cleared Aug 31, 2004
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
K041901
North East Monitoring, Inc.
Cardiovascular · 48d
Cleared Aug 22, 2003
SPIDERVIEW
K032466
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470
General Electric Medical Systems Information Techn
Cardiovascular · 190d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373
Mortara Instrument, Inc.
Cardiovascular · 57d
Cleared Jan 13, 2000
PE 501 PC-ECG MONITOR
K992584
Nhe Corp.
Cardiovascular · 164d
Cleared Dec 28, 1999
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643
Nexan Telemed , Ltd.
Cardiovascular · 61d
Cleared Nov 24, 1999
DIGITRAKPLUS HOLTER RECORDER
K993617
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
DXP1000 HOLTER RECORDER
K993618
Braemar Corp.
Cardiovascular · 29d
Cleared Oct 19, 1999
TES-20
K992425
Tes Electrical Electronic Corp.
Cardiovascular · 90d
Cleared Apr 09, 1999
TRACER
K982617
Heartland Medical Systems, Inc.
Cardiovascular · 256d
Cleared Nov 10, 1998
CMS-2000
K982843
Industrial Technology Research Institute
Cardiovascular · 90d
Cleared Nov 10, 1998
DIGITAL ECG HOLTER RECORDER, MODEL DR512
K982975
Datrix
Cardiovascular · 76d