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DSI

398 FDA 510(k) clearances · Product code

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RecordFirmDate
DATASCOPE MODEL VISA CENTRAL MONITOR (K913576)Accucore, Inc.1992-01-28
HORIZON PACEMAKER DETECTION SOFTWARE (K913339)Mennen Medical, Inc.1992-01-08
ORG-8200A UNIVERSAL SIGNAL HOUSING (K912744)Nihon Kohden America, Inc.1991-12-09
TYPE 9210 S/ECG (K903940)S & W Medico Teknik1991-12-04
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS (K913451)Hewlett-Packard Co.1991-10-31
CARDIOSWISS CM-8 (K910109)Care Systems, Inc.1991-09-23
ACCUCORE TELEMETRY, MODIFICATION (K905506)S & W Medico Teknik1991-09-06
Q-SMART HOLTER SYSTEMS (K910808)Quinton, Inc.1991-07-17
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE (K900385)Parexel Intl. Corp.1991-07-09
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A (K910490)Hewlett-Packard Co.1991-04-26
ARRHYTHMIA 9215 (K900366)S & W Medico Teknik1991-04-26
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION (K910291)Hewlett-Packard Co.1991-04-22
FUKUDA DENSHI MODEL LX-3100 (K903514)Fukuda Denshi USA, Inc.1991-01-30
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) (K900720)Mortara Instrument, Inc.1990-11-05
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 (K900607)Cardiodata Corp.1990-10-16
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION (K903704)Fukuda Denshi USA, Inc.1990-09-07
TRAM PATIENT MONITOR (K900540)Marquette Electronics, Inc.1990-07-17
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 (K900246)Ppg Industries, Inc.1990-07-03
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM (K900319)Siemens Medical Electronics1990-06-28
MODEL 215M PATIENT SIMULATOR (K897074)Dynatech/Nevada, Inc.1990-05-17
PCI MODEL 2041-B TELEMETRY MONITOR (K896775)Accucore, Inc.1990-05-17
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM (K896862)Del Mar Avionics1990-04-18
ELATEC HOLTER ANALYZER (K895806)Ela Medical, Inc.1990-04-04
HTS 820 CARDIAC MONITOR (K896967)Life Sensing Instrument Company, Inc.1990-03-19
GRANDCOR/CARDIOLINE ECT STRESS TESTING (K895547)Grandcor Medical Systems1990-03-13
EKG, ECG KENZ, ECG 302 (K896771)Cambridge Medical Instruments, Inc.1990-02-26
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER (K894543)Del Mar Avionics1990-02-08
FUKUDA DENSHI MODEL DS-3300 ETR (K897063)Fukuda Denshi USA, Inc.1990-02-01
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (K895266)Biosensor Corp.1990-01-26
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (K896103)Advanced Medical Products, Inc.1990-01-18
MODEL DS-3300 DYNASCOPE PATIENT MONITOR (K894628)Fukuda Denshi USA, Inc.1990-01-08
ZYMED MODEL 1610 (K895208)Agilent Technologies1989-12-12
1100 VITAL SIGNS MONITOR (K884643)Criticare Systems, Inc.1989-10-30
CARE 5000 SYSTEM (K894858)Care Systems, Inc.1989-10-12
BEDSIDE MONITORS, BSM-8301A, BSM-8302A (K894692)Nihon Kohden America, Inc.1989-10-02
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA (K894460)Siemens Medical Electronics1989-10-02
DMI PC HOLTER SCANNER (K894285)Diagnostic Medical Instruments1989-09-26
SEER (K882818)Marquette Electronics, Inc.1989-06-22
MAX-1 (EXERCISE ELECTROCARDIOGRAPH) (K890323)Marquette Electronics, Inc.1989-06-16
MEDILOG EXCEL ECG ANALYSIS SYSTEM (K885256)Oxford Medical, Inc.1989-05-31
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM (K891148)Del Mar Avionics1989-05-11
MEDILOG 6000-FD REPORT GENERATOR (K890330)Oxford Medilog, Inc.1989-04-20
MEDILOG EDITOR (K890338)Oxford Medilog, Inc.1989-04-19
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) (K885204)Mennen Medical, Inc.1989-04-19
HTS 220 CARDIAC MONITOR (K884524)Life Sensing Instrument Company, Inc.1989-04-10
SUPERMON ARRHYTHMIA MODULE 7270 (K882206)Kontron Instruments, Inc.1989-04-05
506 NON-INVASIVE VITAL SIGNS MONITOR (K884216)Criticare Systems, Inc.1989-03-16
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL (K884106)Siemens Medical Solutions USA, Inc.1989-03-06
MODEL 499 SSR ANALYSIS SYSTEM (K884887)Del Mar Avionics1989-02-06
E550 ELECTROCARDIOGRAPH (K883440)Burdick Corp.1989-01-17
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 (K884539)Rmv Medical (Romavat, Inc.)1989-01-17
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 (K880505)Ppg Industries, Inc.1988-12-27
CENTURY COLOR TRACE (K884152)Biomedical Systems, Inc.1988-12-15
Q4000 OPTION FOR Q4000 (K882978)Quinton, Inc.1988-11-01
CARDIOMEGA-T (K883410)Grandcor Medical Systems1988-10-17
EPICARDIA PC/FC (K883103)Medicomp, Inc.1988-09-22
HOLTER SCANNER (K881488)Cardiodata Corp.1988-09-20
MODEL MICRO SI AMBULATORY ECG MONITOR (K881905)Advanced Medical Products, Inc.1988-08-02
HORIZON 2000 ARRHYTHMIA MONITORING OPTION (K881273)Mennen Medical, Inc.1988-07-12
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K882513)Cardiac Resucitator Corp.1988-07-12
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) (K880664)Mortara Instrument, Inc.1988-03-09
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM (K870816)Kontron Instruments, Inc.1988-03-01
RHYTHMSCAN (K871572)Brentwood Instruments, Inc.1988-02-22
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE (K873533)Medical Electronics Laboratories, Inc.1988-01-29
CARDIOFAX-V ECG-8110A (K873874)Nihon Kohden America, Inc.1988-01-07
FUKUDA DENSHI MODEL FCP-231 (K874768)Fukuda Denshi USA, Inc.1987-12-18
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM (K873680)Oxford Medilog, Inc.1987-11-23
THE EXPERT MODELS RTS 2000 AND RTS 2000H (K862947)Ocg Technology, Inc.1987-11-04
EPICARIDA, LE (K872837)Medicomp, Inc.1987-11-04
PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR (K871344)Reynolds Medical , Ltd.1987-10-20
MODEL MR-45 AMBULATORY HOLTER MONITOR (K872497)Oxford Medilog, Inc.1987-10-06
LIFESCOPE 12, BSM 8500A PATIENT MONITOR (K872241)Nihon Kohden America, Inc.1987-09-30
HOLTER ST SYSTEM, MODEL NO. 5000-20 (K871389)Holter Data Services1987-09-01
CARDIO-MEGA SYSTEM (K871890)Grandcor Medical Systems1987-06-12
CIRCAMED FULL DISCLOSURE SYSTEM (K871251)Circadian, Inc.1987-05-22
FUKUDA DENSHI MODEL FCP-15 (K871025)Fukuda Denshi USA, Inc.1987-03-24
CARDIOFAX-V ECG-834OA (K865032)Nihon Kohden America, Inc.1987-03-10
CARDIOFAX-V ECG-8240A (K865030)Nihon Kohden America, Inc.1987-03-10
PLURIMUS CARDIAC EVALUATION SYSTEM (K864401)Vivix Corp.1987-03-03
Q-SCAN II AND Q-SCAN III (K864149)Quinton, Inc.1986-12-10
EPICARDIA, PC/FD (K863643)Medicomp, Inc.1986-12-05
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 (K864506)Spacelabs, Inc.1986-11-25
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 (K864505)Spacelabs, Inc.1986-11-24
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM (K863724)Oxford Medilog, Inc.1986-11-20
CASE 12 (K862316)Marquette Electronics, Inc.1986-11-20
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR (K863159)Quinton, Inc.1986-10-06
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM (K862375)Grandcor Medical Systems1986-07-01
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III (K860980)Spacelabs, Inc.1986-05-21
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER (K861240)Mountain View Medical1986-05-02
595 ARRHYTHMIA MONITORING SYSTEM (K852250)Burdick Corp.1986-05-02
SCM-400 HOLTER SYSTEM (K860950)Fukuda Denshi USA, Inc.1986-05-02
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST (K860470)Del Mar Avionics1986-04-30
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER (K860471)Del Mar Avionics1986-04-30
SPACELABS MEDICAL WORKSTATION (K860834)Spacelabs, Inc.1986-04-29
MODEL E 600 ELECTROCARDIOGRAPH (K860767)Kone Instruments, Inc.1986-04-23
PRODIGY AND PRODIGY PLUS (K860167)Cardiodata Corp.1986-03-31
FUKUDA DENSHI CARDIMAX FCP-211 (K860024)Brentwood Instruments, Inc.1986-03-31
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL (K853669)Hewlett-Packard Co.1986-03-31
MEDILOG 2500 SYSTEM (K860078)Oxford Medilog, Inc.1986-02-26
MEDILOG 4500 SYSTEM (K860079)Oxford Medilog, Inc.1986-02-26
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