FDA Product Code
FDA Product Code DSH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2800
510(k) Clearances — 195 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911257 | MR-5200 FULL DISCLOSURE SYSTEM | Mennen Medical, Inc. | 1991-08-19 | Traditional | PDF ↗ |
| K911097 | PR4 | Mortara Instrument, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K912427 | MULTICHANNEL RECORDING SYSTEM | Bionique | 1991-07-26 | Traditional | PDF ↗ |
| K902766 | ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE | Advanced Ischemia Recorders, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K903331 | ROZINN 151 | Rozinn Electronics, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K902486 | CARDIOVISTA | Cardionostics, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K901251 | MODEL 9101 RECORDER/ANALYZER SYSTEM | Aequitron Medical, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION | Del Mar Avionics | 1990-02-13 | Traditional | PDF ↗ |
| K896153 | MODIFIED DR-2C/PMC 100 | General Devices | 1990-01-19 | Traditional | PDF ↗ |
| K895961 | MODEL MC6500 ELECTROCARDIOGRAPH | Cambridge Medical Instruments, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K884126 | E-RAM | Reynolds Medical , Ltd. | 1989-10-30 | Traditional | PDF ↗ |
| K893836 | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) | Quinton Electrophysiology Corp. | 1989-09-08 | Traditional | PDF ↗ |
| K890114 | IMEX RHYTHM TEK | Racom, Inc. | 1989-07-27 | Traditional | PDF ↗ |
| K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) | Edentec Corp. | 1989-06-20 | Traditional | PDF ↗ |
| K892067 | MT9000 CHART RECORDER | Astro-Med, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K890647 | MEDILOG 9000-II AMBULATORY RECORDER | Oxford Medilog, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K884330 | MODEL 463 ELECTROCARDIORECORDER RECORDER | Del Mar Avionics | 1989-01-05 | Traditional | PDF ↗ |
| K880303 | POLYCORD II | Technetics, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K884009 | MODEL 459 ELECTROCARDIOCORDER RECORDER | Del Mar Avionics | 1988-11-09 | Traditional | PDF ↗ |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | Brentwood Instruments, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K874313 | MODEL 492 SSR (TM) RECORDER | Del Mar Avionics | 1988-02-22 | Traditional | PDF ↗ |
| K874571 | PATIENTWATCH (TM) | Advanced Medical Technology, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K873337 | MODEL SSR1 HOLTER MONITOR | Cardiodata Corp. | 1987-10-09 | Traditional | PDF ↗ |
| K872508 | MODEL MICRO FD+ AMBULATORY ECG MONITOR | Advanced Medical Products, Inc. | 1987-09-25 | Traditional | PDF ↗ |
| K871587 | THE TELESCAN C.A.R.E. SYSTEM | Telescan Medical Systems | 1987-08-12 | Traditional | PDF ↗ |
| K872234 | TRANSCOR RADIO-STETHOSCOPE MB | Transcor, Inc. | 1987-08-11 | Traditional | PDF ↗ |
| K872229 | VITEL III, ECG TRANSMITTER | Equimed Corp. | 1987-07-29 | Traditional | PDF ↗ |
| K872246 | MODIFIED MODEL 9431 TELETRACE TRANSMITTER | Medtronic Vascular | 1987-07-21 | Traditional | PDF ↗ |
| K870578 | NIGHTWATCH(TM) SYSTEM | Buckman Co., Inc. | 1987-06-29 | Traditional | PDF ↗ |
| K871944 | FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) | Futurecare Systems, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K872087 | UMSC HOLTER MONITORING KIT | United Medical Supply Co., Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K871045 | DMI AMBULATORY HOLTER MONITOR | Diagnostic Medical Instruments | 1987-05-19 | Traditional | PDF ↗ |
| K870537 | MODEL MICRO ST AMBULATORY ECG MONITOR | Advanced Medical Products, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K870554 | CASSETTE TAPE REPLAY SYSTEM | Research Instrumentation Associates, Inc. | 1987-03-23 | Traditional | PDF ↗ |
| K863922 | VERSAFLEX(TM) DELTA ST(TM) MONITOR | Versaflex Delivery Systems, Inc. | 1986-10-20 | Traditional | PDF ↗ |
| K863863 | CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) | Cardionostics, Inc. | 1986-10-15 | Traditional | PDF ↗ |
| K862526 | MINI-HOLTER, MODEL 2000 | Holter Recorders | 1986-08-25 | Traditional | PDF ↗ |
| K862776 | SPECTRUM POLYCORD I RECORDER SYSTEM | Cardionics, Inc. | 1986-08-18 | Traditional | PDF ↗ |
| K854269 | MODEL 509A PHYSIOCORDER AMBULATORY RECORDER | Del Mar Avionics | 1986-04-11 | Traditional | PDF ↗ |
| K860182 | MODEL MR-35 HOLTER RECORDER | Oxford Medilog, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K860181 | MODEL MR-30 HOLTER RECORDER | Oxford Medilog, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853985 | MVM 4000 HOLTER IV RECORDER | Mountain View Medical | 1985-11-06 | Traditional | PDF ↗ |
| K853262 | CARDIO DATA PACERECORDER PR3 | Cardio Data | 1985-10-11 | Traditional | PDF ↗ |
| K851971 | SERIES 7000/HOLTER RECORDER | Pfizer, Inc. | 1985-06-20 | Traditional | PDF ↗ |
| K842349 | AMBULATORY PH RECORDING DEVICE | Clinical Data Instruments, Inc. | 1985-06-14 | Traditional | PDF ↗ |
| K844940 | SPACELABS MODEL 90201 HOLTER RECORDER | Spacelabs, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K844977 | HOLTER CURA-LITE RECORDER | Cardionostics, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K841654 | DEL MAR AVIONICS 509 NEUROCORDER AMBUL | Del Mar Avionics | 1984-12-11 | Traditional | PDF ↗ |
| K841472 | CARDIORHYTHM 2000 | Biogenix, Inc. | 1984-10-29 | Traditional | PDF ↗ |
| K841868 | MINGOGRAF 7 | Siemens Medical Solutions USA, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K842954 | CARDIONOSTICS HOLTER DURA-LITE RECORDE | Cardionostics, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K833348 | RESPIRATION/8100-HEART RATE RECORDER | Aequitron Medical, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K833349 | EVENT TAPE RECORDER 8293 | Aequitron Medical, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834257 | CARDIODATA PACE RECORDER | Cardio Data | 1984-01-30 | Traditional | PDF ↗ |
| K833823 | HOLTER PERFORMER FEATHER WEIGHT/CASS | Applied Cardiac Systems | 1983-12-01 | Traditional | PDF ↗ |
| K833661 | ELECTROCARDIOCORDER RECORDER 453 | Del Mar Avionics | 1983-11-28 | Traditional | PDF ↗ |
| K832395 | HOLTA-MED RECORDER | Holta-Med | 1983-10-20 | Traditional | PDF ↗ |
| K830907 | AMBULATORY ECG EVENT RECORDER | Brentwood Instruments, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K830915 | OMAR | Oxford Medilog, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K830489 | RECORDER DMI | Diagnostic Medical Instruments | 1983-05-25 | Traditional | PDF ↗ |
| K831262 | DATA IV AMBULATORY MONITOR | Cardio-Scan of Texas | 1983-05-25 | Traditional | PDF ↗ |
| K831184 | CARDIO DATA PACEMAKER RECORDER | Cardio Data | 1983-05-09 | Traditional | PDF ↗ |
| K830519 | CHALLENGER #450 | Transmed, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K822362 | ALTA II ECG RECORDER | Scole Engineering Co. | 1983-01-14 | Traditional | PDF ↗ |
| K823414 | HOLTER KIT MODEL #5000 SERIES | Andover Medical, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K822818 | HOLTER RECORDER & PLAYBACK/ANALYSIS SYS | Marquette Electronics, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K822970 | HOLTER RECORDER | Agilent Technologies | 1982-11-03 | Traditional | PDF ↗ |
| K822363 | ALTA III ECG RECORDER | Scole Engineering Co. | 1982-10-04 | Traditional | PDF ↗ |
| K820256 | MEDILAC #SR4 & SR 40 | Spelna, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821516 | TRACKER-2 CHANNEL ECG TAPE RECORDER | Reynolds Medical , Ltd. | 1982-05-28 | Traditional | PDF ↗ |
| K821453 | CARDIOCASSETTE II #363 | Birtcher Corp. | 1982-05-25 | Traditional | PDF ↗ |
| K813602 | HOLTER PERFORMER | Applied Cardiac Systems | 1982-01-29 | Traditional | PDF ↗ |
| K812920 | EVENT MASTER | Instruments For Cardiac Research | 1981-12-02 | Traditional | PDF ↗ |
| K812763 | ECG MEDATAPE-601 | Hospital Equipment Service | 1981-10-20 | Traditional | PDF ↗ |
| K811253 | CASSETTE READER | American Edwards Laboratories | 1981-07-10 | Traditional | PDF ↗ |
| K810698 | PHARMALOG | Circadian, Inc. | 1981-04-10 | Traditional | PDF ↗ |
| K803222 | ADVANCEMED CCU DOCUMENTOR | American Edwards Laboratories | 1981-01-13 | Traditional | PDF ↗ |
| K803224 | ADVANCEMED HOLTER RECORDERS | American Edwards Laboratories | 1981-01-13 | Traditional | PDF ↗ |
| K802564 | MEDICAL MAGNETIC TAPE RECORDER | Medical Concepts, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801832 | MODEL 9200 VIS-U-SCAN | Del Mar Avionics | 1980-08-27 | Traditional | PDF ↗ |
| K801001 | AMBULATORY MONITOR AM-1 | Burdick Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800214 | CIRCAMED I | Circadian, Inc. | 1980-02-29 | Traditional | PDF ↗ |
| K792079 | MODEL 447 ELECTROCARDIOCORDER | Del Mar Avionics | 1979-12-27 | Traditional | PDF ↗ |
| K792078 | MODEL 449 ELECTROCARDIOCORDER | Del Mar Avionics | 1979-12-27 | Traditional | PDF ↗ |
| K792076 | MODEL 448 PACERCORDER | Del Mar Avionics | 1979-12-27 | Traditional | PDF ↗ |
| K790757 | LIFEPAK 5 MONITOR, CASSETTE, #800923-01 | Physio-Control Corp. | 1979-06-01 | Traditional | PDF ↗ |
| K790476 | QUICKSCAN HOLTER II | Intl. Medical, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K790509 | CARDIOCASSETTE II, AMBULATORY ECG SYSTEM | Cambridge Instruments, Inc. | 1979-03-23 | Traditional | PDF ↗ |
| K790289 | PB-4 REPLAY UNIT | Oxford Medilog, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K790286 | RECORDER, MEDILOG II | Oxford Medilog, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K781843 | RECORDER, HOLTER ELECTROCARDIOGRAM | Hovik Corp. | 1978-11-03 | Traditional | PDF ↗ |
| K772027 | CARDIOCASSETTE II | Cardiodyne, Inc. | 1977-11-09 | Traditional | PDF ↗ |
| K771932 | RECORDER, DINMAP, MODEL 950 | Applied Medical Research | 1977-11-07 | Traditional | PDF ↗ |
| K761074 | DYNAMIC RECORDER (DR-10) | Eldeco | 1976-12-28 | Traditional | PDF ↗ |
| K760508 | ACCUTAPE 24 | Medcraft Corp. | 1976-08-30 | Traditional | PDF ↗ |
Product code DSH · Class II · Cardiovascular. Data: openFDA.