Panels › Cardiovascular › Product code DSI · Class 2
Detector And Alarm, Arrhythmia
Regulation 870.1025
1510(k)s in 12 months (398 all time)
20recalls in 12 months (82 all time)
78recalls that name a 510(k)
Top companies in DSI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 1986 | K855094 | FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA Fukuda Denshi USA, Inc. | DSI |
| Jan 27, 1986 | K854115 | CUSTO PORT 24-H ECG AMBULATORY RECORDER Versacor, Inc. | DSI |
| Jan 8, 1986 | K854282 | PREVIEW XT Cambridge Medical Instruments, Inc. | DSI |
| Dec 9, 1985 | K852892 | MEDILOG M6 Oxford Medilog, Inc. | DSI |
| Dec 4, 1985 | K852654 | CARDIAC COMMUNICATOR 2000 Creative Medical, Inc. | DSI |
| Nov 14, 1985 | K853352 | FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. | DSI |
| Nov 14, 1985 | K852968 | PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM Personal Computers For Medicine, Inc. | DSI |
| Nov 5, 1985 | K853209 | COMPAS 1 Cardiac Care Units, Inc. | DSI |
| Oct 11, 1985 | K853213 | FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON Fukuda Denshi USA, Inc. | DSI |
| Oct 2, 1985 | K851517 | CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO Circadian, Inc. | DSI |
| Sep 12, 1985 | K852514 | MODEL 78560A CENTRAL STATION PATIENT INFO SYS Hewlett-Packard Co. | DSI |
| Jul 30, 1985 | K852270 | LIFESCOPE 8 DEC-8108A AND DEC-8204A Nihon Kohden America, Inc. | DSI |
| Jul 29, 1985 | K851702 | MORTARA INSTRUMENT MODEL EL-1 Mortara Instrument, Inc. | DSI |
| Jul 26, 1985 | K852884 | MEDILOG M1 Oxford Medilog, Inc. | DSI |
| Jul 26, 1985 | K852883 | MEDILOG M3 Oxford Medilog, Inc. | DSI |
| Jul 11, 1985 | K843731 | KENZ 80Z MARK II Suzuken Co., Ltd. | DSI |
| Jun 11, 1985 | K852207 | OXFORD VDT-40 DISPLAY TERMINAL Oxford Medilog, Inc. | DSI |
| Apr 10, 1985 | K850897 | FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES Fukuda Denshi USA, Inc. | DSI |
| Apr 10, 1985 | K844791 | SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A Analogic Corp. | DSI |
| Apr 3, 1985 | K844464 | PROGRAMMABLE PATIENT SIMULATOR Ramford Labs | DSI |
| Mar 1, 1985 | K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG Brentwood Instruments, Inc. | DSI |
| Feb 7, 1985 | K841083 | QUIKPAGE ARRHYTHMIA REPORT GENERATOR Agilent Technologies | DSI |
| Feb 1, 1985 | K850136 | CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM Cardio Data | DSI |
| Feb 1, 1985 | K841084 | ARRHYTHMIA SYSTEM AC-11 Fukuda Denshi USA, Inc. | DSI |
| Jan 10, 1985 | K823844 | HORIZON ECG SYSTEM Beckman Instruments, Inc. | DSI |
| Nov 20, 1984 | K840899 | SERVOMED ARRHYCOMP CENTRAL MONITOR SYS Litton Medical Electronics | DSI |
| Nov 19, 1984 | K842715 | DOCUMENTOR Life Technology | DSI |
| Nov 16, 1984 | K842123 | PERSONAL CL SINGLE-CHANNEL ELECTROCAR Parexel Intl. Corp. | DSI |
| Oct 26, 1984 | K843503 | AEGIS AMBULATORY MONITORING SYSTEM Aegis Medical Systems, Inc. | DSI |
| Oct 22, 1984 | K843513 | EPICARDIA, PC Medicomp, Inc. | DSI |
| Oct 18, 1984 | K843287 | ARRHYTHMIA CENTRAL OCC-7101 Nihon Kohden America, Inc. | DSI |
| Oct 18, 1984 | K842616 | SPACELABS ALPHA PC PATIENT COMPUTER Spacelabs, Inc. | DSI |
| Oct 18, 1984 | K841416 | PEDIATRIC DIAG. CRITERIA OPTION 5600C Hewlett-Packard Co. | DSI |
| Oct 4, 1984 | K842640 | SPACELABS ICR ARRHYTHMIA MASTER I HOLTER Spacelabs, Inc. | DSI |
| Aug 28, 1984 | K841500 | LIFESCOPE 6 OEC-6201 Nihon Kohden America, Inc. | DSI |
| Jul 27, 1984 | K841172 | MONITOR ONE Qmed, Inc. | DSI |
| Jul 2, 1984 | K840622 | CARDIO EXPRESS 100 HOLTER SCANNER Del Mar Avionics | DSI |
| Jun 5, 1984 | K834211 | LEAP FROG Philips Medical Systems (Cleveland), Inc. | DSI |
| Apr 17, 1984 | K834597 | ALPHA MASS STORAGE CARDULE 1895 Spacelabs, Inc. | DSI |
| Apr 17, 1984 | K834397 | HOLTER CARDIOGRAPHY SYS 6201 Instruments For Cardiac Research | DSI |
| Jan 27, 1984 | K832354 | HOLTA-MED INFORMER PLAYBACK Holta-Med | DSI |
| Jan 10, 1984 | K833162 | AMBULATORY MONITORING DEVICE Oxford Medilog, Inc. | DSI |
| Dec 1, 1983 | K831676 | BIOSENSOR ASC SYSTEM Biosensor Corp. | DSI |
| Nov 14, 1983 | K831638 | SINGLE BED ARRHYTHMIA MONITOR AM500 Lifeline Systems, Inc. | DSI |
| Nov 7, 1983 | K832693 | ARRHYTHMIA III CARDULE #1919 Spacelabs, Inc. | DSI |
| Nov 3, 1983 | K832772 | SATURN-24HR. HOLTER SCANNER Hittman Medical Systems | DSI |
| Oct 27, 1983 | K831274 | WLECTROCARDIOGRAPH ECG-7204 Nihon Kohden America, Inc. | DSI |
| Jun 18, 1983 | K830830 | CIRCA MED TWO-CHANNEL Circadian, Inc. | DSI |
| Apr 6, 1983 | K823586 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 Brentwood Instruments, Inc. | DSI |
| Apr 6, 1983 | K823585 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 Brentwood Instruments, Inc. | DSI |
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