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

Company510(k)sRecalls
Philips North America028
Siemens Medical Solutions USA, Inc.270
Hewlett-Packard Co.220
Fukuda Denshi USA, Inc.190
Nihon Kohden America, Inc.180
Spacelabs Healthcare, Inc.116
Spacelabs Medical, Inc.134
Oxford Medilog, Inc.140
Mennen Medical , Ltd.130
Marquette Electronics, Inc.110
Decided510(k)Device and applicantCode
Jan 28, 1992K913576DATASCOPE MODEL VISA CENTRAL MONITOR
Accucore, Inc.
DSI
Jan 8, 1992K913339HORIZON PACEMAKER DETECTION SOFTWARE
Mennen Medical, Inc.
DSI
Dec 9, 1991K912744ORG-8200A UNIVERSAL SIGNAL HOUSING
Nihon Kohden America, Inc.
DSI
Dec 4, 1991K903940TYPE 9210 S/ECG
S & W Medico Teknik, DK
DSI
Oct 31, 1991K913451HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
Hewlett-Packard Co.
DSI
Sep 23, 1991K910109CARDIOSWISS CM-8
Care Systems, Inc.
DSI
Sep 6, 1991K905506ACCUCORE TELEMETRY, MODIFICATION
S & W Medico Teknik, DK
DSI
Jul 17, 1991K910808Q-SMART HOLTER SYSTEMS
Quinton, Inc.
DSI
Jul 9, 1991K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
Parexel Intl. Corp.
DSI
Apr 26, 1991K910490MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
Hewlett-Packard Co.
DSI
Apr 26, 1991K900366ARRHYTHMIA 9215
S & W Medico Teknik, DK
DSI
Apr 22, 1991K910291MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
Hewlett-Packard Co.
DSI
Jan 30, 1991K903514FUKUDA DENSHI MODEL LX-3100
Fukuda Denshi USA, Inc.
DSI
Nov 5, 1990K900720MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
Mortara Instrument, Inc.
DSI
Oct 16, 1990K900607MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
Cardiodata Corp.
DSI
Sep 7, 1990K903704FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
Fukuda Denshi USA, Inc.
DSI
Jul 17, 1990K900540TRAM PATIENT MONITOR
Marquette Electronics, Inc.
DSI
Jul 3, 1990K900246CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
Ppg Industries, Inc.
DSI
Jun 28, 1990K900319SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
Siemens Medical Electronics
DSI
May 17, 1990K897074MODEL 215M PATIENT SIMULATOR
Dynatech/Nevada, Inc.
DSI
May 17, 1990K896775PCI MODEL 2041-B TELEMETRY MONITOR
Accucore, Inc.
DSI
Apr 18, 1990K896862MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
Del Mar Avionics
DSI
Apr 4, 1990K895806ELATEC HOLTER ANALYZER
Ela Medical, Inc.
DSI
Mar 19, 1990K896967HTS 820 CARDIAC MONITOR
Life Sensing Instrument Company, Inc.
DSI
Mar 13, 1990K895547GRANDCOR/CARDIOLINE ECT STRESS TESTING
Grandcor Medical Systems
DSI
Feb 26, 1990K896771EKG, ECG KENZ, ECG 302
Cambridge Medical Instruments, Inc.
DSI
Feb 8, 1990K894543MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
Del Mar Avionics
DSI
Feb 1, 1990K897063FUKUDA DENSHI MODEL DS-3300 ETR
Fukuda Denshi USA, Inc.
DSI
Jan 26, 1990K895266AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
Biosensor Corp.
DSI
Jan 18, 1990K896103MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR
Advanced Medical Products, Inc.
DSI
Jan 8, 1990K894628MODEL DS-3300 DYNASCOPE PATIENT MONITOR
Fukuda Denshi USA, Inc.
DSI
Dec 12, 1989K895208ZYMED MODEL 1610
Agilent Technologies
DSI
Oct 30, 1989K8846431100 VITAL SIGNS MONITOR
Criticare Systems, Inc.
DSI
Oct 12, 1989K894858CARE 5000 SYSTEM
Care Systems, Inc.
DSI
Oct 2, 1989K894692BEDSIDE MONITORS, BSM-8301A, BSM-8302A
Nihon Kohden America, Inc.
DSI
Oct 2, 1989K894460SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
Siemens Medical Electronics
DSI
Sep 26, 1989K894285DMI PC HOLTER SCANNER
Diagnostic Medical Instruments
DSI
Jun 22, 1989K882818SEER
Marquette Electronics, Inc.
DSI
Jun 16, 1989K890323MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
Marquette Electronics, Inc.
DSI
May 31, 1989K885256MEDILOG EXCEL ECG ANALYSIS SYSTEM
Oxford Medical, Inc.
DSI
May 11, 1989K891148MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
Del Mar Avionics
DSI
Apr 20, 1989K890330MEDILOG 6000-FD REPORT GENERATOR
Oxford Medilog, Inc.
DSI
Apr 19, 1989K890338MEDILOG EDITOR
Oxford Medilog, Inc.
DSI
Apr 19, 1989K885204HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
Mennen Medical, Inc.
DSI
Apr 10, 1989K884524HTS 220 CARDIAC MONITOR
Life Sensing Instrument Company, Inc.
DSI
Apr 5, 1989K882206SUPERMON ARRHYTHMIA MODULE 7270
Kontron Instruments, Inc.
DSI
Mar 16, 1989K884216506 NON-INVASIVE VITAL SIGNS MONITOR
Criticare Systems, Inc.
DSI
Mar 6, 1989K884106SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
Siemens Medical Solutions USA, Inc.
DSI
Feb 6, 1989K884887MODEL 499 SSR ANALYSIS SYSTEM
Del Mar Avionics
DSI
Jan 17, 1989K884539HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
Rmv Medical (Romavat, Inc.)
DSI

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