ClearanceBrief
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)
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Top companies in DSI

Decided510(k)Device and applicantCode
Jan 17, 1989K883440E550 ELECTROCARDIOGRAPH
Burdick Corp.
DSI
Dec 27, 1988K880505ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
Ppg Industries, Inc.
DSI
Dec 15, 1988K884152CENTURY COLOR TRACE
Biomedical Systems, Inc.
DSI
Nov 1, 1988K882978Q4000 OPTION FOR Q4000
Quinton, Inc.
DSI
Oct 17, 1988K883410CARDIOMEGA-T
Grandcor Medical Systems
DSI
Sep 22, 1988K883103EPICARDIA PC/FC
Medicomp, Inc.
DSI
Sep 20, 1988K881488HOLTER SCANNER
Cardiodata Corp.
DSI
Aug 2, 1988K881905MODEL MICRO SI AMBULATORY ECG MONITOR
Advanced Medical Products, Inc.
DSI
Jul 12, 1988K882513MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
Cardiac Resucitator Corp.
DSI
Jul 12, 1988K881273HORIZON 2000 ARRHYTHMIA MONITORING OPTION
Mennen Medical, Inc.
DSI
Mar 9, 1988K880664MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
Mortara Instrument, Inc.
DSI
Mar 1, 1988K870816KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
Kontron Instruments, Inc.
DSI
Feb 22, 1988K871572RHYTHMSCAN
Brentwood Instruments, Inc.
DSI
Jan 29, 1988K873533SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
Medical Electronics Laboratories, Inc.
DSI
Jan 7, 1988K873874CARDIOFAX-V ECG-8110A
Nihon Kohden America, Inc.
DSI
Dec 18, 1987K874768FUKUDA DENSHI MODEL FCP-231
Fukuda Denshi USA, Inc.
DSI
Nov 23, 1987K873680MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
Oxford Medilog, Inc.
DSI
Nov 4, 1987K872837EPICARIDA, LE
Medicomp, Inc.
DSI
Nov 4, 1987K862947THE EXPERT MODELS RTS 2000 AND RTS 2000H
Ocg Technology, Inc.
DSI
Oct 20, 1987K871344PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
Reynolds Medical , Ltd., GB
DSI
Oct 6, 1987K872497MODEL MR-45 AMBULATORY HOLTER MONITOR
Oxford Medilog, Inc.
DSI
Sep 30, 1987K872241LIFESCOPE 12, BSM 8500A PATIENT MONITOR
Nihon Kohden America, Inc.
DSI
Sep 1, 1987K871389HOLTER ST SYSTEM, MODEL NO. 5000-20
Holter Data Services
DSI
Jun 12, 1987K871890CARDIO-MEGA SYSTEM
Grandcor Medical Systems
DSI
May 22, 1987K871251CIRCAMED FULL DISCLOSURE SYSTEM
Circadian, Inc.
DSI
Mar 24, 1987K871025FUKUDA DENSHI MODEL FCP-15
Fukuda Denshi USA, Inc.
DSI
Mar 10, 1987K865032CARDIOFAX-V ECG-834OA
Nihon Kohden America, Inc.
DSI
Mar 10, 1987K865030CARDIOFAX-V ECG-8240A
Nihon Kohden America, Inc.
DSI
Mar 3, 1987K864401PLURIMUS CARDIAC EVALUATION SYSTEM
Vivix Corp.
DSI
Dec 10, 1986K864149Q-SCAN II AND Q-SCAN III
Quinton, Inc.
DSI
Dec 5, 1986K863643EPICARDIA, PC/FD
Medicomp, Inc.
DSI
Nov 25, 1986K864506SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
Spacelabs, Inc.
DSI
Nov 24, 1986K864505SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
Spacelabs, Inc.
DSI
Nov 20, 1986K863724MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
Oxford Medilog, Inc.
DSI
Nov 20, 1986K862316CASE 12
Marquette Electronics, Inc.
DSI
Oct 6, 1986K863159Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
Quinton, Inc.
DSI
Jul 1, 1986K862375CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
Grandcor Medical Systems
DSI
May 21, 1986K860980PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
Spacelabs, Inc.
DSI
May 2, 1986K861240BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
Mountain View Medical
DSI
May 2, 1986K860950SCM-400 HOLTER SYSTEM
Fukuda Denshi USA, Inc.
DSI
May 2, 1986K852250595 ARRHYTHMIA MONITORING SYSTEM
Burdick Corp.
DSI
Apr 30, 1986K860471DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
Del Mar Avionics
DSI
Apr 30, 1986K860470DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
Del Mar Avionics
DSI
Apr 29, 1986K860834SPACELABS MEDICAL WORKSTATION
Spacelabs, Inc.
DSI
Apr 23, 1986K860767MODEL E 600 ELECTROCARDIOGRAPH
Kone Instruments, Inc.
DSI
Mar 31, 1986K860167PRODIGY AND PRODIGY PLUS
Cardiodata Corp.
DSI
Mar 31, 1986K860024FUKUDA DENSHI CARDIMAX FCP-211
Brentwood Instruments, Inc.
DSI
Mar 31, 1986K853669MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
Hewlett-Packard Co.
DSI
Feb 26, 1986K860079MEDILOG 4500 SYSTEM
Oxford Medilog, Inc.
DSI
Feb 26, 1986K860078MEDILOG 2500 SYSTEM
Oxford Medilog, Inc.
DSI

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