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)
Top companies in DSH
| Company | 510(k)s | Recalls |
|---|---|---|
| Del Mar Avionics | 15 | 0 |
| Bardy Diagnostics, Inc. | 7 | 0 |
| iRhythm Technologies, Inc. | 6 | 0 |
| Oxford Medilog, Inc. | 6 | 0 |
| Cardiocomm Solutions, Inc. | 4 | 0 |
| Cardionostics, Inc. | 4 | 0 |
| Reynolds Medical , Ltd. | 4 | 0 |
| Vasomedical, Inc. | 4 | 0 |
| Aequitron Medical, Inc. | 3 | 0 |
| American Edwards Laboratories | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 1991 | K911257 | MR-5200 FULL DISCLOSURE SYSTEM Mennen Medical, Inc. | DSH |
| Aug 7, 1991 | K911097 | PR4 Mortara Instrument, Inc. | DSH |
| Jul 26, 1991 | K912427 | MULTICHANNEL RECORDING SYSTEM Bionique | DSH |
| Mar 12, 1991 | K902766 | ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE Advanced Ischemia Recorders, Inc. | DSH |
| Oct 22, 1990 | K903331 | ROZINN 151 Rozinn Electronics, Inc. | DSH |
| Aug 23, 1990 | K902486 | CARDIOVISTA Cardionostics, Inc. | DSH |
| May 22, 1990 | K901251 | MODEL 9101 RECORDER/ANALYZER SYSTEM Aequitron Medical, Inc. | DSH |
| Feb 13, 1990 | K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION Del Mar Avionics | DSH |
| Jan 19, 1990 | K896153 | MODIFIED DR-2C/PMC 100 General Devices | DSH |
| Jan 4, 1990 | K895961 | MODEL MC6500 ELECTROCARDIOGRAPH Cambridge Medical Instruments, Inc. | DSH |
| Oct 30, 1989 | K884126 | E-RAM Reynolds Medical , Ltd. | DSH |
| Sep 8, 1989 | K893836 | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) Quinton Electrophysiology Corp., CA | DSH |
| Jul 27, 1989 | K890114 | IMEX RHYTHM TEK Racom, Inc., GB | DSH |
| Jun 20, 1989 | K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) Edentec Corp. | DSH |
| Jun 5, 1989 | K892067 | MT9000 CHART RECORDER Astro-Med, Inc. | DSH |
| Mar 15, 1989 | K890647 | MEDILOG 9000-II AMBULATORY RECORDER Oxford Medilog, Inc. | DSH |
| Jan 5, 1989 | K884330 | MODEL 463 ELECTROCARDIORECORDER RECORDER Del Mar Avionics | DSH |
| Dec 5, 1988 | K880303 | POLYCORD II Technetics, Inc. | DSH |
| Nov 9, 1988 | K884009 | MODEL 459 ELECTROCARDIOCORDER RECORDER Del Mar Avionics | DSH |
| Aug 2, 1988 | K882366 | RHYTHMSCAN HR HOLTER RECORDER Brentwood Instruments, Inc. | DSH |
| Feb 22, 1988 | K874313 | MODEL 492 SSR (TM) RECORDER Del Mar Avionics | DSH |
| Jan 29, 1988 | K874571 | PATIENTWATCH (TM) Advanced Medical Technology, Inc. | DSH |
| Oct 9, 1987 | K873337 | MODEL SSR1 HOLTER MONITOR Cardiodata Corp. | DSH |
| Sep 25, 1987 | K872508 | MODEL MICRO FD+ AMBULATORY ECG MONITOR Advanced Medical Products, Inc. | DSH |
| Aug 12, 1987 | K871587 | THE TELESCAN C.A.R.E. SYSTEM Telescan Medical Systems | DSH |
| Aug 11, 1987 | K872234 | TRANSCOR RADIO-STETHOSCOPE MB Transcor, Inc. | DSH |
| Jul 29, 1987 | K872229 | VITEL III, ECG TRANSMITTER Equimed Corp. | DSH |
| Jul 21, 1987 | K872246 | MODIFIED MODEL 9431 TELETRACE TRANSMITTER Medtronic Vascular | DSH |
| Jun 29, 1987 | K870578 | NIGHTWATCH(TM) SYSTEM Buckman Co., Inc. | DSH |
| Jun 24, 1987 | K871944 | FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) Futurecare Systems, Inc. | DSH |
| Jun 19, 1987 | K872087 | UMSC HOLTER MONITORING KIT United Medical Supply Co., Inc. | DSH |
| May 19, 1987 | K871045 | DMI AMBULATORY HOLTER MONITOR Diagnostic Medical Instruments | DSH |
| Apr 23, 1987 | K870537 | MODEL MICRO ST AMBULATORY ECG MONITOR Advanced Medical Products, Inc. | DSH |
| Mar 23, 1987 | K870554 | CASSETTE TAPE REPLAY SYSTEM Research Instrumentation Associates, Inc. | DSH |
| Oct 20, 1986 | K863922 | VERSAFLEX(TM) DELTA ST(TM) MONITOR Versaflex Delivery Systems, Inc. | DSH |
| Oct 15, 1986 | K863863 | CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) Cardionostics, Inc. | DSH |
| Aug 25, 1986 | K862526 | MINI-HOLTER, MODEL 2000 Holter Recorders | DSH |
| Aug 18, 1986 | K862776 | SPECTRUM POLYCORD I RECORDER SYSTEM Cardionics, Inc. | DSH |
| Apr 11, 1986 | K854269 | MODEL 509A PHYSIOCORDER AMBULATORY RECORDER Del Mar Avionics | DSH |
| Feb 26, 1986 | K860182 | MODEL MR-35 HOLTER RECORDER Oxford Medilog, Inc. | DSH |
| Feb 26, 1986 | K860181 | MODEL MR-30 HOLTER RECORDER Oxford Medilog, Inc. | DSH |
| Nov 6, 1985 | K853985 | MVM 4000 HOLTER IV RECORDER Mountain View Medical | DSH |
| Oct 11, 1985 | K853262 | CARDIO DATA PACERECORDER PR3 Cardio Data | DSH |
| Jun 20, 1985 | K851971 | SERIES 7000/HOLTER RECORDER Pfizer, Inc. | DSH |
| Jun 14, 1985 | K842349 | AMBULATORY PH RECORDING DEVICE Clinical Data Instruments, Inc. | DSH |
| Feb 14, 1985 | K844940 | SPACELABS MODEL 90201 HOLTER RECORDER Spacelabs, Inc. | DSH |
| Jan 14, 1985 | K844977 | HOLTER CURA-LITE RECORDER Cardionostics, Inc. | DSH |
| Dec 11, 1984 | K841654 | DEL MAR AVIONICS 509 NEUROCORDER AMBUL Del Mar Avionics | DSH |
| Oct 29, 1984 | K841472 | CARDIORHYTHM 2000 Biogenix, Inc. | DSH |
| Oct 24, 1984 | K841868 | MINGOGRAF 7 Siemens Medical Solutions USA, Inc. | DSH |
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