ClearanceBrief
Panels › Cardiovascular › Product code DSH · Class 2

Recorder, Magnetic Tape, Medical

Regulation 870.2800

3510(k)s in 12 months (195 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in DSH

Company510(k)sRecalls
Del Mar Avionics150
Bardy Diagnostics, Inc.70
iRhythm Technologies, Inc.60
Oxford Medilog, Inc.60
Cardiocomm Solutions, Inc.40
Cardionostics, Inc.40
Reynolds Medical , Ltd.40
Vasomedical, Inc.40
Aequitron Medical, Inc.30
American Edwards Laboratories30
Decided510(k)Device and applicantCode
Sep 4, 1984K842954CARDIONOSTICS HOLTER DURA-LITE RECORDE
Cardionostics, Inc.
DSH
Apr 17, 1984K833349EVENT TAPE RECORDER 8293
Aequitron Medical, Inc.
DSH
Apr 17, 1984K833348RESPIRATION/8100-HEART RATE RECORDER
Aequitron Medical, Inc.
DSH
Jan 30, 1984K834257CARDIODATA PACE RECORDER
Cardio Data
DSH
Dec 1, 1983K833823HOLTER PERFORMER FEATHER WEIGHT/CASS
Applied Cardiac Systems
DSH
Nov 28, 1983K833661ELECTROCARDIOCORDER RECORDER 453
Del Mar Avionics
DSH
Oct 20, 1983K832395HOLTA-MED RECORDER
Holta-Med
DSH
Jul 28, 1983K830907AMBULATORY ECG EVENT RECORDER
Brentwood Instruments, Inc.
DSH
Jul 7, 1983K830915OMAR
Oxford Medilog, Inc.
DSH
May 25, 1983K831262DATA IV AMBULATORY MONITOR
Cardio-Scan of Texas
DSH
May 25, 1983K830489RECORDER DMI
Diagnostic Medical Instruments
DSH
May 9, 1983K831184CARDIO DATA PACEMAKER RECORDER
Cardio Data
DSH
Apr 12, 1983K830519CHALLENGER #450
Transmed, Inc.
DSH
Jan 14, 1983K822362ALTA II ECG RECORDER
Scole Engineering Co.
DSH
Dec 30, 1982K823414HOLTER KIT MODEL #5000 SERIES
Andover Medical, Inc.
DSH
Dec 30, 1982K822818HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
Marquette Electronics, Inc.
DSH
Nov 3, 1982K822970HOLTER RECORDER
Agilent Technologies
DSH
Oct 4, 1982K822363ALTA III ECG RECORDER
Scole Engineering Co.
DSH
Jun 25, 1982K820256MEDILAC #SR4 & SR 40
Spelna, Inc.
DSH
May 28, 1982K821516TRACKER-2 CHANNEL ECG TAPE RECORDER
Reynolds Medical , Ltd.
DSH
May 25, 1982K821453CARDIOCASSETTE II #363
Birtcher Corp.
DSH
Jan 29, 1982K813602HOLTER PERFORMER
Applied Cardiac Systems
DSH
Dec 2, 1981K812920EVENT MASTER
Instruments For Cardiac Research
DSH
Oct 20, 1981K812763ECG MEDATAPE-601
Hospital Equipment Service
DSH
Jul 10, 1981K811253CASSETTE READER
American Edwards Laboratories
DSH
Apr 10, 1981K810698PHARMALOG
Circadian, Inc.
DSH
Jan 13, 1981K803224ADVANCEMED HOLTER RECORDERS
American Edwards Laboratories
DSH
Jan 13, 1981K803222ADVANCEMED CCU DOCUMENTOR
American Edwards Laboratories
DSH
Nov 12, 1980K802564MEDICAL MAGNETIC TAPE RECORDER
Medical Concepts, Inc.
DSH
Aug 27, 1980K801832MODEL 9200 VIS-U-SCAN
Del Mar Avionics
DSH
May 28, 1980K801001AMBULATORY MONITOR AM-1
Burdick Corp.
DSH
Feb 29, 1980K800214CIRCAMED I
Circadian, Inc.
DSH
Dec 27, 1979K792079MODEL 447 ELECTROCARDIOCORDER
Del Mar Avionics
DSH
Dec 27, 1979K792078MODEL 449 ELECTROCARDIOCORDER
Del Mar Avionics
DSH
Dec 27, 1979K792076MODEL 448 PACERCORDER
Del Mar Avionics
DSH
Jun 1, 1979K790757LIFEPAK 5 MONITOR, CASSETTE, #800923-01
Physio-Control Corp.
DSH
Jun 1, 1979K790476QUICKSCAN HOLTER II
Intl. Medical, Inc.
DSH
Mar 23, 1979K790509CARDIOCASSETTE II, AMBULATORY ECG SYSTEM
Cambridge Instruments, Inc.
DSH
Feb 27, 1979K790289PB-4 REPLAY UNIT
Oxford Medilog, Inc.
DSH
Feb 27, 1979K790286RECORDER, MEDILOG II
Oxford Medilog, Inc.
DSH
Nov 3, 1978K781843RECORDER, HOLTER ELECTROCARDIOGRAM
Hovik Corp.
DSH
Nov 9, 1977K772027CARDIOCASSETTE II
Cardiodyne, Inc.
DSH
Nov 7, 1977K771932RECORDER, DINMAP, MODEL 950
Applied Medical Research
DSH
Dec 28, 1976K761074DYNAMIC RECORDER (DR-10)
Eldeco
DSH
Aug 30, 1976K760508ACCUTAPE 24
Medcraft Corp.
DSH

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