Detector And Alarm, Arrhythmia
FDA product code DSI · 385 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1025
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 2026-01-23
DSI
1990-11-05
DSI
1990-10-16
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
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DSI
1990-09-07
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
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DSI
1990-07-17
TRAM PATIENT MONITOR
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DSI
1990-07-03
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
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DSI
1990-06-28
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
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DSI
1990-05-17
MODEL 215M PATIENT SIMULATOR
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DSI
1990-05-17
PCI MODEL 2041-B TELEMETRY MONITOR
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DSI
1990-04-18
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
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DSI
1990-04-04
ELATEC HOLTER ANALYZER
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DSI
1990-03-19
HTS 820 CARDIAC MONITOR
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DSI
1990-03-13
GRANDCOR/CARDIOLINE ECT STRESS TESTING
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DSI
1990-02-26
EKG, ECG KENZ, ECG 302
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DSI
1990-02-08
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
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DSI
1990-02-01
FUKUDA DENSHI MODEL DS-3300 ETR
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DSI
1990-01-26
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
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DSI
1990-01-18
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR
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DSI
1990-01-08
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
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DSI
1989-12-12
ZYMED MODEL 1610
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DSI
1989-10-30
1100 VITAL SIGNS MONITOR
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DSI
1989-10-12
CARE 5000 SYSTEM
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DSI
1989-10-02
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
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DSI
1989-10-02
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
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DSI
1989-09-26
DMI PC HOLTER SCANNER
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DSI
1989-06-22
SEER
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DSI
1989-06-16
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
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DSI
1989-05-31
MEDILOG EXCEL ECG ANALYSIS SYSTEM
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DSI
1989-05-11
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
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DSI
1989-04-20
MEDILOG 6000-FD REPORT GENERATOR
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DSI
1989-04-19
MEDILOG EDITOR
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DSI
1989-04-19
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
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DSI
1989-04-10
HTS 220 CARDIAC MONITOR
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DSI
1989-04-05
SUPERMON ARRHYTHMIA MODULE 7270
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DSI
1989-03-16
506 NON-INVASIVE VITAL SIGNS MONITOR
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DSI
1989-03-06
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
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DSI
1989-02-06
MODEL 499 SSR ANALYSIS SYSTEM
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DSI
1989-01-17
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
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DSI
1989-01-17
E550 ELECTROCARDIOGRAPH
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DSI
1988-12-27
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
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DSI
1988-12-15
CENTURY COLOR TRACE
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DSI
1988-11-01
Q4000 OPTION FOR Q4000
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DSI
1988-10-17
CARDIOMEGA-T
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DSI
1988-09-22
EPICARDIA PC/FC
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DSI
1988-09-20
HOLTER SCANNER
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DSI
1988-08-02
MODEL MICRO SI AMBULATORY ECG MONITOR
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DSI
1988-07-12
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
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DSI
1988-07-12
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
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DSI
1988-03-09
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
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DSI
1988-03-01
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
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DSI
1988-02-22
RHYTHMSCAN
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DSI
1988-01-29
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
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DSI
1988-01-07
CARDIOFAX-V ECG-8110A
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DSI
1987-12-18
FUKUDA DENSHI MODEL FCP-231
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DSI
1987-11-23
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
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DSI
1987-11-04
EPICARIDA, LE
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DSI
1987-11-04
THE EXPERT MODELS RTS 2000 AND RTS 2000H
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DSI
1987-10-20
PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
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DSI
1987-10-06
MODEL MR-45 AMBULATORY HOLTER MONITOR
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DSI
1987-09-30
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
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DSI
1987-09-01
HOLTER ST SYSTEM, MODEL NO. 5000-20
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DSI
1987-06-12
CARDIO-MEGA SYSTEM
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DSI
1987-05-22
CIRCAMED FULL DISCLOSURE SYSTEM
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DSI
1987-03-24
FUKUDA DENSHI MODEL FCP-15
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DSI
1987-03-10
CARDIOFAX-V ECG-834OA
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DSI
1987-03-10
CARDIOFAX-V ECG-8240A
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DSI
1987-03-03
PLURIMUS CARDIAC EVALUATION SYSTEM
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DSI
1986-12-10
Q-SCAN II AND Q-SCAN III
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DSI
1986-12-05
EPICARDIA, PC/FD
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DSI
1986-11-25
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
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DSI
1986-11-24
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
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DSI
1986-11-20
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
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DSI
1986-11-20
CASE 12
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DSI
1986-10-06
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
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DSI
1986-07-01
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
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DSI
1986-05-21
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
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DSI
1986-05-02
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
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DSI
1986-05-02
SCM-400 HOLTER SYSTEM
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DSI
1986-05-02
595 ARRHYTHMIA MONITORING SYSTEM
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DSI
1986-04-30
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
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DSI
1986-04-30
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
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DSI
1986-04-29
SPACELABS MEDICAL WORKSTATION
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DSI
1986-04-23
MODEL E 600 ELECTROCARDIOGRAPH
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DSI
1986-03-31
PRODIGY AND PRODIGY PLUS
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DSI
1986-03-31
FUKUDA DENSHI CARDIMAX FCP-211
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DSI
1986-03-31
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
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DSI
1986-02-26
MEDILOG 4500 SYSTEM
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DSI
1986-02-26
MEDILOG 2500 SYSTEM
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DSI
1986-02-12
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
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DSI
1986-01-27
CUSTO PORT 24-H ECG AMBULATORY RECORDER
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DSI
1986-01-08
PREVIEW XT
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DSI
1985-12-09
MEDILOG M6
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DSI
1985-12-04
CARDIAC COMMUNICATOR 2000
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DSI
1985-11-14
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
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DSI
1985-11-14
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
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DSI
1985-11-05
COMPAS 1
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DSI
1985-10-11
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
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DSI
1985-10-02
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
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DSI
1985-09-12
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
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DSI
1985-07-30
LIFESCOPE 8 DEC-8108A AND DEC-8204A
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DSI
1985-07-29
MORTARA INSTRUMENT MODEL EL-1
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