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
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 May 08, 2009
ZIO PATCH, MODEL Z100
K090363
iRhythm Technologies, Inc.
Cardiovascular · 84d
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 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
Cleared Jan 29, 1998
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
K971670
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 268d
Cleared Aug 20, 1997
DM-400 HOLTER ECG CASSETTE RECORDER
K970298
Diagnostic Monitoring
Cardiovascular · 205d
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared May 05, 1997
MEDILOG FD4
K970902
Oxford Instruments Medical Systems
Cardiovascular · 55d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174
Del Mar Avionics
Cardiovascular · 211d
Cleared Mar 07, 1997
MODEL 700
K944180
Memtec Corp.
Cardiovascular · 924d
Cleared Jul 31, 1996
NORTHEAST MONITORING DR180
K960925
North East Monitoring, Inc.
Cardiovascular · 147d
Cleared Oct 12, 1995
VITALOGRAPH 2110 SOFTWARE INTERFACE
K950854
Vitalograph , Ltd.
Cardiovascular · 227d
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