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
121–144 of 195
Cleared Feb 22, 1988
MODEL 492 SSR (TM) RECORDER
K874313
Del Mar Avionics
Cardiovascular · 125d
Cleared Jan 29, 1988
PATIENTWATCH (TM)
K874571
Advanced Medical Technology, Inc.
Cardiovascular · 85d
Cleared Oct 09, 1987
MODEL SSR1 HOLTER MONITOR
K873337
Cardiodata Corp.
Cardiovascular · 51d
Cleared Sep 25, 1987
MODEL MICRO FD+ AMBULATORY ECG MONITOR
K872508
Advanced Medical Products, Inc.
Cardiovascular · 93d
Cleared Aug 12, 1987
THE TELESCAN C.A.R.E. SYSTEM
K871587
Telescan Medical Systems
Cardiovascular · 110d
Cleared Aug 11, 1987
TRANSCOR RADIO-STETHOSCOPE MB
K872234
Transcor, Inc.
Cardiovascular · 62d
Cleared Jul 29, 1987
VITEL III, ECG TRANSMITTER
K872229
Equimed Corp.
Cardiovascular · 50d
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 Jun 24, 1987
FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)
K871944
Futurecare Systems, Inc.
Cardiovascular · 36d
Cleared Jun 19, 1987
UMSC HOLTER MONITORING KIT
K872087
United Medical Supply Co., Inc.
Cardiovascular · 18d
Cleared May 19, 1987
DMI AMBULATORY HOLTER MONITOR
K871045
Diagnostic Medical Instruments
Cardiovascular · 63d
Cleared Apr 23, 1987
MODEL MICRO ST AMBULATORY ECG MONITOR
K870537
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Mar 23, 1987
CASSETTE TAPE REPLAY SYSTEM
K870554
Research Instrumentation Associates, Inc.
Cardiovascular · 41d
Cleared Oct 20, 1986
VERSAFLEX(TM) DELTA ST(TM) MONITOR
K863922
Versaflex Delivery Systems, Inc.
Cardiovascular · 12d
Cleared Oct 15, 1986
CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)
K863863
Cardionostics, Inc.
Cardiovascular · 12d
Cleared Aug 25, 1986
MINI-HOLTER, MODEL 2000
K862526
Holter Recorders
Cardiovascular · 54d
Cleared Aug 18, 1986
SPECTRUM POLYCORD I RECORDER SYSTEM
K862776
Cardionics, Inc.
Cardiovascular · 27d
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 Nov 06, 1985
MVM 4000 HOLTER IV RECORDER
K853985
Mountain View Medical
Cardiovascular · 40d
Cleared Oct 11, 1985
CARDIO DATA PACERECORDER PR3
K853262
Cardio Data
Cardiovascular · 67d
Cleared Jun 20, 1985
SERIES 7000/HOLTER RECORDER
K851971
Pfizer, Inc.
Cardiovascular · 44d