ClearanceBrief
Panels › Cardiovascular › Product code DPS · Class 2

Electrocardiograph

Regulation 870.2340

8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in DPS

Company510(k)sRecalls
Smiths Medical PM, Inc.038
Mortara Instrument, Inc.211
Nihon Kohden America, Inc.210
Edan Instruments, Inc.191
Quinton, Inc.170
WELCH ALLYN, INC/MORTARA016
Hewlett-Packard Co.150
Philips North America014
Burdick Corp.120
Philips Medical Systems92
Decided510(k)Device and applicantCode
May 24, 2006K052511CARDIOFAX CE, MODEL ECG-1500 A
Nihon Kohden America, Inc.
DPS
Apr 25, 2006K050674PHYSIOGLOVE ES
Commwell , Ltd.
DPS
Apr 19, 2006K060167ATRIA 3100, ATRIA 6100
Cardiac Science Corporation
DPS
Mar 28, 2006K052898IQMARK EZ STRESS
Brentwood Medical Technology Corp.
DPS
Jan 31, 2006K051163GALIX ECG PROFESSIONAL STATION
Galix Biomedical Instrumentation, Inc.
DPS
Jan 13, 2006K052295CARDIOSOFT PC ECG, USB VERSION
Cardiosoft, L.P.
DPS
Dec 16, 2005K052303READMYHEART, MODEL RMH2.0
Dailycare Biomedical, Inc., TW
DPS
Nov 30, 2005K053083DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
Datrix
DPS
Oct 5, 2005K051534CARDIOLINE AR 600, AR 1200, AR 2100
Et Medical Devices Spa, IT
DPS
Aug 26, 2005K052049PHILIPS 12-LEAD ALGORITHM
Philips Medical Systems
DPS
Jul 14, 2005K050620READMYHEART, MODEL RMH3.0
Dailycare Biomedical, Inc., TW
DPS
Jun 29, 2005K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
Heartlab, Inc.
DPS
May 19, 2005K051126CARDIOSCOPE SONOPLUS 3000
Pulsonic Ag, Medical Technology
DPS
May 4, 2005K050686CARDIOVIT AT-10PLUS
Schiller AG, CH
DPS
Apr 26, 2005K043380MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Monebo Technologies, Inc.
DPS
Mar 22, 2005K05007412-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
Welch Allyn, Inc.
DPS
Feb 22, 2005K043074LIBERTY SYSTEM
Inovise Medical, Inc.
DPS
Jan 6, 2005K042827CARDIOFAX CE, MODEL PEA-1110K
Nihon Kohden America, Inc.
DPS
Jan 6, 2005K042814READMYHEART
Dailycare Biomedical, Inc.
DPS
Aug 27, 2004K042177MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Ge Medical Systems Information Technologies
DPS
Jul 7, 2004K033488CMI MAGNETOCARDIOGRAPH
Cmi Cardiomag Imaging, Inc.
DPS
Apr 14, 2004K031557CARDIOVIT AT-102
Schiller AG, CH
DPS
Apr 6, 2004K040313HRV TOOLS
Del Mar Reynolds Medical, Ltd.
DPS
Oct 31, 2003K032145AUDICOR UPGRADE SYSTEM
Inovise Medical, Inc.
DPS
Oct 3, 2003K032200ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
Remco Italia S.P.A.
DPS
Aug 1, 2003K024283CARDIODIRECT, MODELS 12M, 12I, 12S
Reynolds Medical , Ltd.
DPS
Jul 25, 2003K031182ELI 200+ AUDICOR
Mortara Instrument, Inc.
DPS
Jul 3, 2003K031422PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
Philips Medical Systems
DPS
Jun 11, 2003K030535EKGCARD SYSTEM
Qrs Diagnostic, LLC
DPS
Jun 11, 2003K030104PRIME ECG SYSTEM
Meridian Medical Technologies, Inc.
DPS
May 29, 2003K024278PACEART SYSTEM
Medtronic Vascular
DPS
May 9, 2003K021230HERO
Medical Decision Networks
DPS
Sep 6, 2002K022618X-SCRIBE II
Mortara Instrument, Inc.
DPS
Jul 16, 2002K022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Cambridge Heart, Inc.
DPS
Jul 16, 2002K022149CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Cambridge Heart, Inc.
DPS
May 29, 2002K013615MICRO-INDUCTION 1000 SYSTEM
Harbinger Medical, Inc.
DPS
May 8, 2002K021171Q-STRESS ECHO BED
Medical Positioning, Inc.
DPS
Apr 30, 2002K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
Cardiocomm Solutions, Inc., CA
DPS
Apr 25, 2002K020708PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
Philips Medical Systems, Inc.
DPS
Mar 26, 2002K014262COSMED QUARK C12/QUARK T12
Cosmed Srl
DPS
Mar 6, 2002K012414PRIME ECG SYSTEM
Meridian Medical Technologies, Inc.
DPS
Feb 6, 2002K013717BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
Brentwood Medical Technology Corp.
DPS
Dec 13, 2001K013367CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
Reynolds Medical , Ltd.
DPS
Dec 13, 2001K012686CAIRD TECHNOLOGY HOLTER 2000
Caird Technology
DPS
Nov 21, 2001K013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Cambridge Heart, Inc.
DPS
Nov 21, 2001K013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Cambridge Heart, Inc.
DPS
Oct 10, 2001K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
National Custom Ent., Inc.
DPS
Oct 10, 2001K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
National Custom Ent., Inc.
DPS
Sep 26, 2001K012540BLY-501 ADAPTOR
Micromedical Industries, Ltd., AU
DPS
Jul 5, 2001K011436MOBILE-PATIENT VIEWER
Data Critical Corporation
DPS

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