FDA Product Code
FDA Product Code DSF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2810
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Edentec Corp. | 1991-08-29 | Traditional | PDF ↗ |
| K912929 | DASH IV | Astro-Med, Inc. | 1991-08-13 | Traditional | PDF ↗ |
| K905856 | MODEL 556 MONITOR | Ge Medical Systems Information Technologies | 1991-01-11 | Traditional | PDF ↗ |
| K902586 | GRI LASERGRAPH(TM) ECG PAPER | Gri Medical Products, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K902230 | COLORADO COLOR IMAGING RECORDER | Honeywell, Inc. | 1990-06-19 | Traditional | PDF ↗ |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | Gabriel Medical, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | S & W Medico Teknik | 1990-01-26 | Traditional | PDF ↗ |
| K894922 | WR3500 AND WR3600 SERIES RECORDERS | Western Graphtec | 1990-01-26 | Traditional | PDF ↗ |
| K894736 | MT96000 PAPER CHART RECORDER | Astro-Med, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K894607 | PAQ10 PAPER CHART RECORDER | Protocol Systems, Inc. | 1989-10-26 | Traditional | PDF ↗ |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Edentec Corp. | 1989-08-25 | Traditional | PDF ↗ |
| K885058 | CARDIOCAP(TM) DR-104 REPORTER | Datex Division Instrumentarium Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Somatics, Inc. | 1989-06-02 | Traditional | PDF ↗ |
| K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | Mennen Medical, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K890142 | A10 ULTRASCOPE RECORDER | Ems Medical, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K884911 | CORTRONIC SCR1000 | Cortronic Corp. | 1989-01-13 | Traditional | PDF ↗ |
| K884388 | EDENTEC MODEL 4700 SCANNER | Edentec Corp. | 1989-01-10 | Traditional | PDF ↗ |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | Edentec Corp. | 1988-12-28 | Traditional | PDF ↗ |
| K881831 | WS 800R THERMAL ARRAY RECORDER | Nihon Kohden America, Inc. | 1988-07-14 | Traditional | PDF ↗ |
| K881346 | LIFESTAT 1600 PRINTER | Physio-Control Corp. | 1988-06-09 | Traditional | PDF ↗ |
| K880781 | DATALOGGER CHART RECORDER | Air-Shields, Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K880554 | VSM(R) R2 PAPER CHART RECORDER | Physio-Control Corp. | 1988-05-06 | Traditional | PDF ↗ |
| K872822 | MODEL 78576A PAPER CHART RECORDER | Hewlett-Packard Co. | 1987-11-04 | Traditional | PDF ↗ |
| K870538 | MODEL 192 PRINTER | Advanced Medical Products, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K870119 | FIBRE OPTIC STRIP CHART RECORDER | Apex Imaging Corp. | 1987-04-10 | Traditional | PDF ↗ |
| K870039 | IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM | Par Microsystems Corp. | 1987-02-12 | Traditional | PDF ↗ |
| K863331 | SIREDOC 60 AND SIREDOC 220 | Siemens Medical Solutions USA, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K862596 | DR-2C (MODIFICATION) | General Devices | 1986-09-26 | Traditional | PDF ↗ |
| K855045 | MODEL 535 NEO-TRAK RECORDER | Ge Medical Systems Information Technologies | 1986-05-16 | Traditional | PDF ↗ |
| K854866 | LONG TERM RECORDER RAG 1200 | Nihon Kohden America, Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K851625 | SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 | Eaton Medical Group | 1985-11-19 | Traditional | PDF ↗ |
| K852487 | FUKUDA DENSHI MODEL AU-5001-5003 THERMAL | Fukuda Denshi USA, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K851626 | SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE | Eaton Medical Group | 1985-06-26 | Traditional | PDF ↗ |
| K851274 | OHMEDA MODEL 0001/0003 RECORDER | Ohmeda Medical | 1985-05-15 | Traditional | PDF ↗ |
| K850365 | RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE | Eaton Medical Group | 1985-04-09 | Traditional | PDF ↗ |
| K850487 | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER | Novametrix Medical Systems, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K850146 | SIREDOC, PAPER CHART RECORDER | Siemens Medical Solutions USA, Inc. | 1985-02-12 | Traditional | PDF ↗ |
| K843836 | THERMAL GRAYSCALE RF-100 | Fukuda Denshi USA, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K832998 | 2-CHANNEL RECORDER | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K833000 | I-CHANNEL RECORDER | Litton Medical Electronics | 1984-06-01 | Traditional | PDF ↗ |
| K833656 | NARCOTRACE 40 - NT40 | Narco Bio-Systems | 1984-05-09 | Traditional | PDF ↗ |
| K832754 | MONITORING SYSTEM AS100-AS115 RECORD | Air-Shields, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K831134 | PHOENIX 60/60 PROCESSOR MODULE | Phoenix Corp. | 1983-11-07 | Traditional | PDF ↗ |
| K832012 | MEDICAL ELECTRONICS-PRINTER CLOCK | Litton Medical Electronics | 1983-10-31 | Traditional | PDF ↗ |
| K830321 | VENTURE II MONITORING SYSTEM | Rae Medical Corp. | 1983-06-03 | Traditional | PDF ↗ |
| K830315 | DUAL CHANNEL RECORDER #78574A | Hewlett-Packard Co. | 1983-03-31 | Traditional | PDF ↗ |
| K822978 | MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 | Siemens Corp. | 1982-12-15 | Traditional | PDF ↗ |
| K822983 | MINGOCARD 7 & MINGOPHONE 7 | Siemens Corp. | 1982-11-24 | Traditional | PDF ↗ |
| K823210 | MODEL 525 NEO-TRAK NEONATAL RECORDER | Ge Medical Systems Information Technologies | 1982-11-24 | Traditional | PDF ↗ |
| K822432 | CENTURION CHART RECORDER | Clinical Data, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K821612 | MODEL 16800 TREND RECORDER | Healthdyne, Inc. | 1982-07-14 | Traditional | PDF ↗ |
| K821173 | EVENTMASTER 3 HOLTER EVENT SCANNER | Instruments For Cardiac Research | 1982-05-18 | Traditional | PDF ↗ |
| K820033 | CARDIOVUE ACCESSORY CART | Diasonics, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K812608 | VASCULAB #R12B | Medasonics, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K811540 | SPACELABS' SYSTEM AUTORECORDER | Spacelabs, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K811453 | NOVATRACER RECORDER | Novametrix Medical Systems, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K811254 | PAPER CHART RECORDER | American Edwards Laboratories | 1981-07-10 | Traditional | PDF ↗ |
| K810166 | 1,2,3 CHANNELL RECORDERS (AR150,AR250,-) | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810169 | CENTRAL STATION CONTROLLER AC100/CE100 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810167 | SINGLE CHANNELL RECORDER AR110 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K803225 | ADVANCEMED EXAMINER | American Edwards Laboratories | 1981-01-13 | Traditional | PDF ↗ |
| K801830 | MODEL 9300 ELECTROCARDIOVALIDATOR | Del Mar Avionics | 1980-08-27 | Traditional | PDF ↗ |
| K801549 | MODEL R11 SINGLE CHANNEL CHART RECORDER | Medasonics, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K801485 | SERIES 602 CKG RECORDER (MODIFIED) | Cardio Kinetics, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K800851 | SERIES 602 CKGTM RECORDER | Cardio Kinetics, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K792105 | CRITIKON DUAL CHANNEL RECORDER | Critikon Company, LLC | 1979-10-26 | Traditional | PDF ↗ |
| K792099 | 50MM WRITER MODEL CVM 9529 | C-V Monitors Corp. | 1979-10-26 | Traditional | PDF ↗ |
| K790825 | LS-8 VISICORDER | Honeywell, Inc. | 1979-05-31 | Traditional | PDF ↗ |
| K781867 | WRITER, GEMINI-3 | C-V Monitors Corp. | 1979-01-05 | Traditional | PDF ↗ |
| K781873 | RECORDER, STRIP CHART WITH PRINTER | Midwest Analog & Digital, Inc. | 1979-01-05 | Traditional | PDF ↗ |
| K781115 | PRINTER, DIGITAL | Output, Inc. | 1978-10-06 | Traditional | PDF ↗ |
| K780597 | ECG PAPER, 3 CHANNEL | Abco Dealers, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K780677 | 4600 RECORDER | G & W Applied Science Laboratories | 1978-05-17 | Traditional | PDF ↗ |
| K780640 | DRY SILVER PROCESSOR MODEL 1226 | Honeywell, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K780245 | RECORDER, RE-100P HOT STYLUS STRIP CHART | Waters Assoc., Inc. | 1978-03-27 | Traditional | PDF ↗ |
| K780338 | MINYSTAG MN-1 | Lkb Instruments, Inc. | 1978-03-15 | Traditional | PDF ↗ |
| K772333 | RECORDER, PAPER, ECG | Telectronics, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K772052 | PHYSIOLOGICAL RECORDER MODEL 721A | Datascope Corp. | 1977-11-22 | Traditional | PDF ↗ |
| K772054 | PHYSIOLOGICAL RECORDER MODEL 740 | Datascope Corp. | 1977-11-22 | Traditional | PDF ↗ |
| K772048 | SINGLE & DUAL CHANNEL RECORDER | Hewlett-Packard Co. | 1977-11-09 | Traditional | PDF ↗ |
| K771372 | SYSTEM II | Irex Corp. | 1977-08-04 | Traditional | PDF ↗ |
| K770946 | RECORD, MODEL 702, I.L. | Instrumentation Laboratory CO | 1977-07-05 | Traditional | PDF ↗ |
| K770342 | RECORDER, CHART, MODEL 5536 | Hudson Oxygen Therapy Sales Co. | 1977-03-01 | Traditional | PDF ↗ |
| K761077 | TREND ANALYZER | Eldeco | 1976-12-28 | Traditional | PDF ↗ |
| K761055 | CALCULATOR PLOTTER (MODEL 9872A) | Hewlett-Packard Co. | 1976-12-09 | Traditional | PDF ↗ |
| K760676 | LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE | Physio-Control Corp. | 1976-10-13 | Traditional | PDF ↗ |
| K760539 | RECORDER (#78640A) | Hewlett-Packard Co. | 1976-09-09 | Traditional | PDF ↗ |
Product code DSF · Class I · Cardiovascular. Data: openFDA.