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 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 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 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 Nov 28, 1983
ELECTROCARDIOCORDER RECORDER 453
K833661
Del Mar Avionics
Cardiovascular · 41d
Cleared Jul 07, 1983
OMAR
K830915
Oxford Medilog, Inc.
Cardiovascular · 107d
Cleared Dec 30, 1982
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Jul 10, 1981
CASSETTE READER
K811253
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jan 13, 1981
ADVANCEMED CCU DOCUMENTOR
K803222
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCEMED HOLTER RECORDERS
K803224
American Edwards Laboratories
Cardiovascular · 25d
Cleared Aug 27, 1980
MODEL 9200 VIS-U-SCAN
K801832
Del Mar Avionics
Cardiovascular · 26d
Cleared May 28, 1980
AMBULATORY MONITOR AM-1
K801001
Burdick Corp.
Cardiovascular · 33d
Cleared Dec 27, 1979
MODEL 448 PACERCORDER
K792076
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 449 ELECTROCARDIOCORDER
K792078
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 447 ELECTROCARDIOCORDER
K792079
Del Mar Avionics
Cardiovascular · 73d
Cleared Jun 01, 1979
LIFEPAK 5 MONITOR, CASSETTE, #800923-01
K790757
Physio-Control Corp.
Cardiovascular · 45d