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)
Get daily alerts for DSISample briefCSV

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
May 15, 2009K090834EPICARDIA 5000
Medicomp, Inc.
DSI
Feb 3, 2009K083287AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
Corventis, Inc.
DSI
Jan 16, 2009K083517INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
DSI
Nov 7, 2008K082475REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
Medtronic, Inc.
DSI
Oct 3, 2008K082633INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
DSI
Jul 31, 2008K081444BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
Braemar, Inc.
DSI
May 29, 2008K081257CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd., IL
DSI
May 19, 2008K071889DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
GE Healthcare
DSI
Dec 18, 2007K071995CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Card Guard Scientific Survival , Ltd., IL
DSI
Nov 21, 2007K073140VITALOGIK MODEL 4000/4500
Mennen Medical , Ltd., IL
DSI
Nov 21, 2007K071655REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
Medtronic, Inc.
DSI
Nov 21, 2007K071641REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
Medtronic, Inc.
DSI
Sep 25, 2007K071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
Datascope Corp.
DSI
Mar 16, 2007K062976MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
Ge Medical Systems Information Technologies
DSI
Feb 23, 2007K070260STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
Philips Medical Systems
DSI
Apr 25, 2006K053263CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
Cardionet, Inc.
DSI
Dec 20, 2005K052288VITALOGIK
Mennen Medical , Ltd., IL
DSI
Dec 16, 2005K052160ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
Welch Allyn, Inc.
DSI
Jun 14, 2005K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
Analogic Corp.
DSI
May 3, 2005K050605SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
Spacelabs Medical, Inc.
DSI
Mar 4, 2005K050175SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
Spacelabs Medical, Inc.
DSI
Mar 23, 2004K024213SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
Siemens Medical Solutions USA, Inc.
DSI
Oct 31, 2003K033305INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
Draeger Medical Systems, Inc.
DSI
Oct 10, 2003K032858THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
Philips Medizin Systeme Boblingen GmbH, DE
DSI
Aug 19, 2003K031433SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
Siemens Medical Solutions USA, Inc.
DSI
Aug 13, 2003K032370CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
Ge Medical Systems Information Technologies
DSI
Dec 3, 2002K023798MODIFICATION TO ENVOY PATIENT MONITOR
Mennen Medical , Ltd., IL
DSI
Aug 28, 2002K020550PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
Datascope Corp.
DSI
Aug 21, 2002K022453MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
Welch Allyn Protocol, Inc.
DSI
Aug 21, 2002K013046COSMOS SYSTEM
Spacelabs Medical, Inc.
DSI
Jul 24, 2002K021376DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
Datex-Ohmeda
DSI
Jun 28, 2002K021097QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
Spacelabs Medical, Inc.
DSI
May 8, 2002K021300MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
Philips Medical Systems
DSI
May 7, 2002K021251ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
Philips Medical Systems
DSI
Feb 11, 2002K012467SOLAR 8000M SYSTEM
General Electric Medical Systems Information Techn
DSI
Feb 7, 2002K002604CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
Invivo Research, Inc.
DSI
Feb 6, 2002K020084FUKUDA DENSHI DYNASCOPE MODEL DS-5700
Fukuda Denshi USA, Inc.
DSI
Feb 1, 2002K012241CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
Cardionet, Inc.
DSI
Jan 18, 2002K014159PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
Philips Medical Systems, Inc.
DSI
Oct 3, 2001K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
Medical Data Electronics
DSI
Aug 20, 2001K011339QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
Spacelabs Burdick, Inc.
DSI
Aug 17, 2001K012461SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
DSI
Aug 16, 2001K011784MODIFICATION TO ENVOY PATIENT MONITOR
Mennen Medical , Ltd., IL
DSI
Jul 2, 2001K011824AGILENT M2636B TELEMON B MONITOR (TELEMON B)
Agilent Technologies, Inc.
DSI
May 8, 2001K001120ENVOY PATIENT MONITOR
Mennen Medical , Ltd., IL
DSI
Feb 22, 2001K002758AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
Agilent Technologies Deutschland GmbH, DE
DSI
Feb 8, 2001K002068ORG-9200A
Nihon Kohden America, Inc.
DSI
Jan 25, 2001K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
Quinton, Inc.
DSI
Dec 21, 2000K003246SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
Siemens Medical Solutions USA, Inc.
DSI
Nov 9, 2000K003179SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
Siemens Medical Solutions USA, Inc.
DSI

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.