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
May 8, 1997K970545DASH 1000 PATIENT MONITOR
Marquette Medical Systems, Inc.
DSI
May 1, 1997K964187FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
Fukuda Denshi USA, Inc.
DSI
Apr 2, 1997K952912SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
Spacelabs Medical, Inc.
DSI
Mar 25, 1997K962970SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
Spacelabs Medical, Inc.
DSI
Mar 21, 1997K963057FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
Fukuda Denshi USA, Inc.
DSI
Feb 24, 1997K962827ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
Marquette Electronics, Inc.
DSI
Jan 29, 1997K962291SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Jan 22, 1997K955023BRENTWOOD PC-ECG
Brentwood Medical Products, Inc.
DSI
Jan 17, 1997K962404SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Jan 8, 1997K964122HP STAR ST AND ARRHHYTHMIA SOFTWARE
Hewlett-Packard Co.
DSI
Oct 10, 1996K961165HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
Hewlett-Packard Co.
DSI
Oct 2, 1996K960418EAGLE PATIENT MONITOR
Marquette Electronics, Inc.
DSI
Aug 9, 1996K961139EAGLE PATIENT MONITOR MODEL 3000/3100
Marquette Electronics, Inc.
DSI
Jul 8, 1996K955743SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Jun 7, 1996K955059OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
Siemens Medical Solutions USA, Inc.
DSI
Jun 7, 1996K952054SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
Siemens Medical Solutions USA, Inc.
DSI
May 29, 1996K954852SOLAR 9000 ANESTHESIA INFORMATION MONITOR
Marquette Electronics, Inc.
DSI
May 22, 1996K952417QUEST EXERCISE STRESS SYSTEM
Burdick, Inc.
DSI
Apr 4, 1996K935732CARDIO PERFECT ST 2001
Cardio Control BV, NL
DSI
Nov 27, 1995K945944NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
Nihon Kohden America, Inc.
DSI
Oct 6, 1995K951370ZYMED TELEMETRY SYSTEM; MODEL T8010
Zymed Medical Instrumentation
DSI
Oct 4, 1995K9513711481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
Siemens Medical Solutions USA, Inc.
DSI
Oct 3, 1995K950821HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
Hewlett-Packard Co.
DSI
Sep 26, 1995K952885SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
Spacelabs Medical, Inc.
DSI
Aug 15, 1995K945429SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)
Spacelabs Medical, Inc.
DSI
Jun 28, 1995K9421963050 DIASCOPE NT PATIENT MONITOR
S & W Medico Teknik A/S, DK
DSI
Jun 27, 1995K946306SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
May 24, 1995K944422BSM-8800A BEDSIDE MONITOR
Nihon Kohden America, Inc.
DSI
May 24, 1995K935877NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
Nihon Kohden America, Inc.
DSI
May 17, 1995K942058SPACELABS MEDICAL ECG MODULE (MODEL 90492)
Spacelabs Medical, Inc.
DSI
May 10, 1995K9453841481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
Siemens Medical Solutions USA, Inc.
DSI
Apr 10, 1995K944350SC 6000/ SC 6000P/ R50
Siemens Medical Solutions USA, Inc.
DSI
Apr 10, 1995K933177SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
Siemens Medical Solutions USA, Inc.
DSI
Jan 30, 1995K942147PACIFIC COMMUNICATIONS MODEL 1100
Accucore, Inc.
DSI
Dec 5, 1994K935846MODEL ACUITY CENTRAL STATION
Protocol Systems, Inc.
DSI
Oct 27, 1994K925510MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
Spacelabs Medical, Inc.
DSI
Apr 19, 1994K920790MARQUETTE EAGLE MONITOR
Marquette Electronics, Inc.
DSI
Feb 7, 1994K931716BATTERY PACK 1017LA
Portable Power Systems, Inc.
DSI
Sep 3, 1993K930095SPACELABS MEDICAL PATIENT MONITOR
Spacelabs Medical, Inc.
DSI
Jul 20, 1993K923747CC ARHYTHMIS MONITORING OPTION
Hewlett-Packard Co.
DSI
Feb 25, 1993K925411MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR
Accucore, Inc.
DSI
Feb 17, 1993K922027AMBULATORY (HOLTER) RECORDING, MODIFICATION
Biosensor Corp.
DSI
Dec 18, 1992K920154BSM-8800A BEDSIDE MONITOR
Nihon Kohden America, Inc.
DSI
Dec 15, 1992K924672ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)
Agilent Technologies
DSI
Sep 3, 1992K920743DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
Nihon Kohden America, Inc.
DSI
May 28, 1992K914092BSM-2100A CONFIGURED PATIENT MONITOR
Nihon Kohden America, Inc.
DSI
Apr 29, 1992K913117ZB-860PA MULTIPARAMETER TRANSMITTER
Nihon Kohden America, Inc.
DSI
Apr 27, 1992K915153ESCORT-LINK ARRHYTHMIA OPTION 23L
Medical Data Electronics
DSI
Mar 19, 1992K910929OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.
Ohmeda Medical
DSI
Feb 14, 1992K911835RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM
Gs Microsystems
DSI

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