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
97–120 of 195
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 Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
K823414
Andover Medical, Inc.
Cardiovascular · 45d
Cleared May 25, 1982
CARDIOCASSETTE II #363
K821453
Birtcher Corp.
Cardiovascular · 11d
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
QUICKSCAN HOLTER II
K790476
Intl. Medical, Inc.
Cardiovascular · 88d
Cleared Jun 01, 1979
LIFEPAK 5 MONITOR, CASSETTE, #800923-01
K790757
Physio-Control Corp.
Cardiovascular · 45d
Cleared Feb 27, 1979
RECORDER, MEDILOG II
K790286
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
PB-4 REPLAY UNIT
K790289
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Nov 07, 1977
RECORDER, DINMAP, MODEL 950
K771932
Applied Medical Research
Cardiovascular · 24d