FDA Product Code
FDA Product Code DSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 398 records · page 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K855094 | FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA | Fukuda Denshi USA, Inc. | 1986-02-12 | Traditional | PDF ↗ |
| K854115 | CUSTO PORT 24-H ECG AMBULATORY RECORDER | Versacor, Inc. | 1986-01-27 | Traditional | PDF ↗ |
| K854282 | PREVIEW XT | Cambridge Medical Instruments, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K852892 | MEDILOG M6 | Oxford Medilog, Inc. | 1985-12-09 | Traditional | PDF ↗ |
| K852654 | CARDIAC COMMUNICATOR 2000 | Creative Medical, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K852968 | PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM | Personal Computers For Medicine, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K853352 | FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K853209 | COMPAS 1 | Cardiac Care Units, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K853213 | FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON | Fukuda Denshi USA, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K851517 | CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO | Circadian, Inc. | 1985-10-02 | Traditional | PDF ↗ |
| K852514 | MODEL 78560A CENTRAL STATION PATIENT INFO SYS | Hewlett-Packard Co. | 1985-09-12 | Traditional | PDF ↗ |
| K852270 | LIFESCOPE 8 DEC-8108A AND DEC-8204A | Nihon Kohden America, Inc. | 1985-07-30 | Traditional | PDF ↗ |
| K851702 | MORTARA INSTRUMENT MODEL EL-1 | Mortara Instrument, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K852884 | MEDILOG M1 | Oxford Medilog, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K852883 | MEDILOG M3 | Oxford Medilog, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K843731 | KENZ 80Z MARK II | Suzuken Co., Ltd. | 1985-07-11 | Traditional | PDF ↗ |
| K852207 | OXFORD VDT-40 DISPLAY TERMINAL | Oxford Medilog, Inc. | 1985-06-11 | Traditional | PDF ↗ |
| K844791 | SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A | Analogic Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K850897 | FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES | Fukuda Denshi USA, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K844464 | PROGRAMMABLE PATIENT SIMULATOR | Ramford Labs | 1985-04-03 | Traditional | PDF ↗ |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Brentwood Instruments, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K841083 | QUIKPAGE ARRHYTHMIA REPORT GENERATOR | Agilent Technologies | 1985-02-07 | Traditional | PDF ↗ |
| K850136 | CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM | Cardio Data | 1985-02-01 | Traditional | PDF ↗ |
| K841084 | ARRHYTHMIA SYSTEM AC-11 | Fukuda Denshi USA, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K823844 | HORIZON ECG SYSTEM | Beckman Instruments, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K840899 | SERVOMED ARRHYCOMP CENTRAL MONITOR SYS | Litton Medical Electronics | 1984-11-20 | Traditional | PDF ↗ |
| K842715 | DOCUMENTOR | Life Technology | 1984-11-19 | Traditional | PDF ↗ |
| K842123 | PERSONAL CL SINGLE-CHANNEL ELECTROCAR | Parexel Intl. Corp. | 1984-11-16 | Traditional | PDF ↗ |
| K843503 | AEGIS AMBULATORY MONITORING SYSTEM | Aegis Medical Systems, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K843513 | EPICARDIA, PC | Medicomp, Inc. | 1984-10-22 | Traditional | PDF ↗ |
| K843287 | ARRHYTHMIA CENTRAL OCC-7101 | Nihon Kohden America, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K842616 | SPACELABS ALPHA PC PATIENT COMPUTER | Spacelabs, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K841416 | PEDIATRIC DIAG. CRITERIA OPTION 5600C | Hewlett-Packard Co. | 1984-10-18 | Traditional | PDF ↗ |
| K842640 | SPACELABS ICR ARRHYTHMIA MASTER I HOLTER | Spacelabs, Inc. | 1984-10-04 | Traditional | PDF ↗ |
| K841500 | LIFESCOPE 6 OEC-6201 | Nihon Kohden America, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K841172 | MONITOR ONE | Qmed, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K840622 | CARDIO EXPRESS 100 HOLTER SCANNER | Del Mar Avionics | 1984-07-02 | Traditional | PDF ↗ |
| K834211 | LEAP FROG | Philips Medical Systems (Cleveland), Inc. | 1984-06-05 | Traditional | PDF ↗ |
| K834597 | ALPHA MASS STORAGE CARDULE 1895 | Spacelabs, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834397 | HOLTER CARDIOGRAPHY SYS 6201 | Instruments For Cardiac Research | 1984-04-17 | Traditional | PDF ↗ |
| K832354 | HOLTA-MED INFORMER PLAYBACK | Holta-Med | 1984-01-27 | Traditional | PDF ↗ |
| K833162 | AMBULATORY MONITORING DEVICE | Oxford Medilog, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K831676 | BIOSENSOR ASC SYSTEM | Biosensor Corp. | 1983-12-01 | Traditional | PDF ↗ |
| K831638 | SINGLE BED ARRHYTHMIA MONITOR AM500 | Lifeline Systems, Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K832693 | ARRHYTHMIA III CARDULE #1919 | Spacelabs, Inc. | 1983-11-07 | Traditional | PDF ↗ |
| K832772 | SATURN-24HR. HOLTER SCANNER | Hittman Medical Systems | 1983-11-03 | Traditional | PDF ↗ |
| K831274 | WLECTROCARDIOGRAPH ECG-7204 | Nihon Kohden America, Inc. | 1983-10-27 | Traditional | PDF ↗ |
| K830830 | CIRCA MED TWO-CHANNEL | Circadian, Inc. | 1983-06-18 | Traditional | PDF ↗ |
| K823585 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 | Brentwood Instruments, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K823586 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 | Brentwood Instruments, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K830029 | SIRECUST 400 | Analogic Corp. | 1983-03-31 | Traditional | PDF ↗ |
| K830407 | ECLIPSE | Diagnostic Medical Instruments | 1983-03-24 | Traditional | PDF ↗ |
| K830306 | HEARTRATE PLUS ECG CARDULE #1918 | Spacelabs, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830013 | EPI CARDIA SYS. - AMBULATORY MONITOR | Medicomp, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K830163 | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS | Intl. Business Machines | 1983-02-18 | Traditional | PDF ↗ |
| K822968 | ELECTROCARDIOGRAPH INTERPRETER | Suzuken Co., Ltd. | 1982-12-15 | Traditional | PDF ↗ |
| K822616 | LS6 ARRYTHMIA DISCRIMINATOR | Life Science Instrumentation, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K821711 | CARDIO TEHCHANALYZER | Cardio Technology , Ltd. | 1982-10-04 | Traditional | PDF ↗ |
| K822718 | SERIES 7000 BEDSIDE PATIENT MONITOR | Marquette Electronics, Inc. | 1982-10-04 | Traditional | PDF ↗ |
| K822030 | MULTIPLE LEAD ARRHYTHMIA MODULE | Marquette Electronics, Inc. | 1982-09-28 | Traditional | PDF ↗ |
| K820881 | MEMOPORT C | Litton Medical Electronics | 1982-05-18 | Traditional | PDF ↗ |
| K820856 | EVENTMASTER 2 | Instruments For Cardiac Research | 1982-04-29 | Traditional | PDF ↗ |
| K820438 | QUINTON Q2000 ETT MONITORING SYSTEM | Quinton, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K820477 | ALGORITHM OF THE ARRHYTHMIA MON. SYS | Hewlett-Packard Co. | 1982-04-15 | Traditional | PDF ↗ |
| K812914 | MICRO-PREPROCESSOR UNIT | General Electric Co. | 1981-12-29 | Traditional | PDF ↗ |
| K813287 | CC-201 ECG MONITORING SYSTEMS | Anthro-Metrics Corp. | 1981-12-14 | Traditional | PDF ↗ |
| K812149 | CARDIO-DATA SYSTEM, #MARK III | Cardio Data | 1981-08-31 | Traditional | PDF ↗ |
| K811581 | ARRHYTHMIA FUNCTION BLOCK | Honeywell, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K810940 | THE BETA | Burdick Corp. | 1981-07-16 | Traditional | PDF ↗ |
| K811792 | ARRYTHMIA PRINTER OPTION | American Edwards Laboratories | 1981-07-10 | Traditional | PDF ↗ |
| K811527 | CC-103 | Anthro-Metrics Corp. | 1981-06-16 | Traditional | PDF ↗ |
| K811122 | DEL MAR AVIONICS MODELS 9400 & 9401 | Del Mar Avionics | 1981-06-12 | Traditional | PDF ↗ |
| K803208 | SIRECUST 358 | Siemens Corp. | 1981-05-27 | Traditional | PDF ↗ |
| K810027 | DATAMEDIX PECGASYS SYSTEM | Datamedix | 1981-03-26 | Traditional | PDF ↗ |
| K802900 | HEART SENTINEL | Totemite Medical Electronics | 1981-03-11 | Traditional | PDF ↗ |
| K801903 | SERIES 4000 STRESS & EXERCISE SYSTEM | Instruments For Cardiac Research | 1981-03-11 | Traditional | PDF ↗ |
| K803282 | GUARDIAN MONITOR (CARDIOVASCULAR) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-02-27 | Traditional | PDF ↗ |
| K802312 | CC101 ECG MONITORING SYSTEM | Anthro-Metrics Corp. | 1981-01-07 | Traditional | PDF ↗ |
| K802472 | BIOMETRIC ERG SYSTEM | Biometric Analysis Group, Inc. | 1980-11-26 | Traditional | PDF ↗ |
| K802033 | OXFORD INTENSIVE CARE PATIENT MON. SYS | Oxford Medilog, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K802272 | COMPUTER ECG TERMINAL | Compumed, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K802103 | ECG RECALL & EDIT PRODUCT VERSION-A3601 | General Electric Co. | 1980-09-26 | Traditional | PDF ↗ |
| K801831 | EVALUATOR #9500 DYNAMIC ELEC/SCANNER | Del Mar Avionics | 1980-09-09 | Traditional | PDF ↗ |
| K801762 | MICRO-PROCESSOR UNIT #A3600AC | General Electric Co. | 1980-08-27 | Traditional | PDF ↗ |
| K792081 | SPECTRA CENTRAL PT MONITORING SYS | American Optical Corp. | 1979-11-13 | Traditional | PDF ↗ |
| K791632 | COMPU-SCAN | Hittman Medical Systems | 1979-11-13 | Traditional | PDF ↗ |
| K791487 | MODEL 78520A ARRHYTHMIA MONITORING SYS | Hewlett-Packard Co. | 1979-08-28 | Traditional | PDF ↗ |
| K791424 | DCG-VII ELECTROCARDIOSCANNER | Del Mar Avionics | 1979-08-28 | Traditional | PDF ↗ |
| K790837 | ARRHYTHMIA II CARDULE | Spacelabs, Inc. | 1979-05-16 | Traditional | PDF ↗ |
| K790287 | ANALYZER, MEDILOG II | Oxford Medilog, Inc. | 1979-02-28 | Traditional | PDF ↗ |
| K781911 | ECG ANALYZER, HIGH SPEED | Cardio-Dynamics Laboratories, Inc. | 1978-11-30 | Traditional | PDF ↗ |
| K781845 | CAMSCAN SYSTEM | American Optical Corp. | 1978-11-20 | Traditional | PDF ↗ |
| K780432 | ARRHYTHMIA PROGRAM MODULE | Midwest Analog & Digital, Inc. | 1978-05-26 | Traditional | PDF ↗ |
| K780343 | ARRHYTHMIA TREND ENHANCEMENT | American Optical Corp. | 1978-04-18 | Traditional | PDF ↗ |
| K772360 | ARRHYTHMIA MODULE | General Electric Co. | 1978-01-12 | Traditional | PDF ↗ |
| K771374 | SCANNER TREND SYSTEM | Instruments For Cardiac Research | 1977-08-04 | Traditional | PDF ↗ |
| K760368 | MONITORING & STRESS TESTING EQUIPMENT | Advanced Medical, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K760884 | MICRO-COMPUTER ARRHYTHONIA SYSTEM | Spacelabs, Inc. | 1976-12-09 | Traditional | PDF ↗ |
Product code DSI · Class II · Cardiovascular. Data: openFDA.