ClearanceBrief
Panels › Cardiovascular › Product code DQK · Class 2

Computer, Diagnostic, Programmable

Regulation 870.1425

29510(k)s in 12 months (442 all time)
2recalls in 12 months (125 all time)
121recalls that name a 510(k)
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Top companies in DQK

Company510(k)sRecalls
Biosense Webster, Inc.347
Boston Scientific1524
Siemens Medical Solutions USA, Inc.525
St Jude Medical231
Ge Medical Systems Information Technologies185
Edwards Lifesciences152
Merge Healthcare Incorporated215
ABBOTT MEDICAL140
Acutus Medical, Inc.120
Spacelabs Healthcare48
Decided510(k)Device and applicantCode
Jan 8, 1992K911615HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300
Diagnostic Monitoring Software
DQK
Oct 16, 1991K913193MODEL 100 CENTRAL STATION
Protocol Systems, Inc.
DQK
Feb 28, 1991K905248NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
Advanced Technology Laboratories, Inc.
DQK
Jan 15, 1991K905100HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
Hewlett-Packard Co.
DQK
Dec 17, 1990K900814CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS
Intellimetrics Instrument Corp.
DQK
Oct 2, 1990K896017THE OPHTHIMUS SYSTEM
Hightech Vision
DQK
Sep 4, 1990K902716PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)
Prucka Engineering, Inc.
DQK
May 18, 1989K892113Q5000 PC WORKSTATION
Quinton, Inc.
DQK
Oct 13, 1988K883152EP-STAT
Coherent Systems, Inc.
DQK
Jun 2, 1988K880879WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
Ppg Industries, Inc.
DQK
May 31, 1988K881770EPICARDIA LE/FD
Medicomp, Inc.
DQK
Feb 5, 1988K874171MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
Hewlett-Packard Co.
DQK
Jan 6, 1988K872928LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
Fidelity Medical, Inc.
DQK
Jul 6, 1987K865010MICOR
Siemens Medical Solutions USA, Inc.
DQK
Jun 19, 1987K871436PREDICTOR
Corazonix Corp.
DQK
May 11, 1987K865035RECORD KEEPING/DATA MANAGEMENT SYSTEM
Critical Care Systems, Inc.
DQK
May 11, 1987K864583CARDIAC PERFORMANCE MONITOR
Vascular Technology Incorporated
DQK
Dec 8, 1986K860854CRITICALC
Cygnus of South Florida, Inc.
DQK
Oct 31, 1986K862740QUINTON Q.CATH
Quinton, Inc.
DQK
Feb 12, 1986K855055PDS 9000 PATIENT DATA MGMT. SYSTEM
Marquette Electronics, Inc.
DQK
Jul 12, 1985K851637SIRECUST 425, RESPECTIVELY SIRECUST 430
Siemens Medical Solutions USA, Inc.
DQK
May 28, 1985K850627SPACELABS-GENERAL SYSTEM LINK
Spacelabs, Inc.
DQK
Dec 19, 1984K842339COMPUSTRESS STRESS TESTING SYS
Intl. Medical, Inc.
DQK
Jul 6, 1984K840875MULTIVARIATE DIGITAL CARDIOGRAPH
Clinical Microsystems Intl.
DQK
Apr 30, 1984K834567Q3000
Quinton, Inc.
DQK
Dec 29, 1981K812739VITALOG PMS-8 MONITOR
Vitalog Corp.
DQK
Sep 25, 1981K812354KONTRON PMS 7000
Kontron Instruments, Inc.
DQK
Mar 27, 1981K810750PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
General Electric Co.
DQK
Mar 27, 1981K810731MODEL IM1000 INTEGRATED MONITOR
Gould, Inc.
DQK
Feb 5, 1981K801810PACEMAKER PATIENT MGMT. SYSTEM
Siemens Elema AB
DQK
Apr 24, 1980K800766ECHO-COMP
Digisonics, Inc.
DQK
Apr 8, 1980K800092COMBISON COMPUTER
Kt Medical, Inc.
DQK
Jan 11, 1980K792135DYE CURVE EVALUATOR
Sci-Pro, Inc.
DQK
Jan 4, 1980K792677DATABASE MANAGEMENT & REPORTING SYSTEM
Honeywell, Inc.
DQK
Dec 27, 1979K792525IREX CARDIOPLAN
Irex Corp.
DQK
Oct 2, 1979K791776ARRHYTHMIA II EDITOR
Spacelabs, Inc.
DQK
Feb 23, 1979K782072QUINTON STATUS 1000
Quinton, Inc.
DQK
Jun 19, 1978K780468CLINICAL GRAPHICS ANALYZER
Numonics Corp.
DQK
May 26, 1978K780768MODEL 5621A INTERFACE
Hewlett-Packard Co.
DQK
Apr 28, 1978K780530AUTOMATED PHYSIOLOGIC PROFILER
Bd Becton Dickinson Vacutainer Systems Preanalytic
DQK
Jun 2, 1977K770705CARDIAC ACQUISITION SYSTEM, ICR 2001
Instruments For Cardiac Research
DQK
Oct 13, 1976K760767MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM
Honeywell, Inc.
DQK

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