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
73–96 of 195
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 May 22, 1990
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251
Aequitron Medical, Inc.
Cardiovascular · 67d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793
Del Mar Avionics
Cardiovascular · 138d
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227
Edentec Corp.
Cardiovascular · 77d
Cleared Mar 15, 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647
Oxford Medilog, Inc.
Cardiovascular · 33d
Cleared Jan 05, 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330
Del Mar Avionics
Cardiovascular · 83d
Cleared Nov 09, 1988
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009
Del Mar Avionics
Cardiovascular · 49d
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366
Brentwood Instruments, Inc.
Cardiovascular · 55d
Cleared Feb 22, 1988
MODEL 492 SSR (TM) RECORDER
K874313
Del Mar Avionics
Cardiovascular · 125d
Cleared Jul 21, 1987
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246
Medtronic Vascular
Cardiovascular · 40d
Cleared Jun 29, 1987
NIGHTWATCH(TM) SYSTEM
K870578
Buckman Co., Inc.
Cardiovascular · 139d
Cleared Apr 11, 1986
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269
Del Mar Avionics
Cardiovascular · 170d
Cleared Feb 26, 1986
MODEL MR-30 HOLTER RECORDER
K860181
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
MODEL MR-35 HOLTER RECORDER
K860182
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Jun 20, 1985
SERIES 7000/HOLTER RECORDER
K851971
Pfizer, Inc.
Cardiovascular · 44d
Cleared Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940
Spacelabs, Inc.
Cardiovascular · 56d
Cleared Dec 11, 1984
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654
Del Mar Avionics
Cardiovascular · 232d
Cleared Oct 24, 1984
MINGOGRAF 7
K841868
Siemens Medical Solutions USA, Inc.
Cardiovascular · 173d
Cleared Apr 17, 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
EVENT TAPE RECORDER 8293
K833349
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Nov 28, 1983
ELECTROCARDIOCORDER RECORDER 453
K833661
Del Mar Avionics
Cardiovascular · 41d
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907
Brentwood Instruments, Inc.
Cardiovascular · 129d