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
145–168 of 195
Cleared Jun 14, 1985
AMBULATORY PH RECORDING DEVICE
K842349
Clinical Data Instruments, Inc.
Cardiovascular · 364d
Cleared Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940
Spacelabs, Inc.
Cardiovascular · 56d
Cleared Jan 14, 1985
HOLTER CURA-LITE RECORDER
K844977
Cardionostics, Inc.
Cardiovascular · 19d
Cleared Dec 11, 1984
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654
Del Mar Avionics
Cardiovascular · 232d
Cleared Oct 29, 1984
CARDIORHYTHM 2000
K841472
Biogenix, Inc.
Cardiovascular · 203d
Cleared Oct 24, 1984
MINGOGRAF 7
K841868
Siemens Medical Solutions USA, Inc.
Cardiovascular · 173d
Cleared Sep 04, 1984
CARDIONOSTICS HOLTER DURA-LITE RECORDE
K842954
Cardionostics, Inc.
Cardiovascular · 39d
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 Jan 30, 1984
CARDIODATA PACE RECORDER
K834257
Cardio Data
Cardiovascular · 54d
Cleared Dec 01, 1983
HOLTER PERFORMER FEATHER WEIGHT/CASS
K833823
Applied Cardiac Systems
Cardiovascular · 29d
Cleared Nov 28, 1983
ELECTROCARDIOCORDER RECORDER 453
K833661
Del Mar Avionics
Cardiovascular · 41d
Cleared Oct 20, 1983
HOLTA-MED RECORDER
K832395
Holta-Med
Cardiovascular · 93d
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907
Brentwood Instruments, Inc.
Cardiovascular · 129d
Cleared Jul 07, 1983
OMAR
K830915
Oxford Medilog, Inc.
Cardiovascular · 107d
Cleared May 25, 1983
RECORDER DMI
K830489
Diagnostic Medical Instruments
Cardiovascular · 99d
Cleared May 25, 1983
DATA IV AMBULATORY MONITOR
K831262
Cardio-Scan of Texas
Cardiovascular · 37d
Cleared May 09, 1983
CARDIO DATA PACEMAKER RECORDER
K831184
Cardio Data
Cardiovascular · 28d
Cleared Apr 12, 1983
CHALLENGER #450
K830519
Transmed, Inc.
Cardiovascular · 54d
Cleared Jan 14, 1983
ALTA II ECG RECORDER
K822362
Scole Engineering Co.
Cardiovascular · 161d
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 Nov 03, 1982
HOLTER RECORDER
K822970
Agilent Technologies
Cardiovascular · 26d
Cleared Oct 04, 1982
ALTA III ECG RECORDER
K822363
Scole Engineering Co.
Cardiovascular · 59d