FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

FDA 510(k) Number Submission Date Device Name Applicant
K030575 02/24/2003 MODIFICATION TO SOLAR 9500 INFORMATION MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042642 09/27/2004 AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033964 12/22/2003 SOLAR 9500 INFORMATION MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K080251 01/31/2008 APEXPRO TELEMETRY SYSTEMS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042525 09/17/2004 CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K043415 12/13/2004 CENTRICITY PACS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K090702 03/17/2009 MODIFICATION TO DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031561 05/19/2003 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032513 08/14/2003 T-WAVE ALTERNANS (TWA) ALGORITHM OPTION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K040559 03/03/2004 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032346 07/30/2003 UNITY NETWORK IS PATIENT VIEWER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032369 08/01/2003 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033365 10/21/2003 APEXPRO FH TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033672 11/24/2003 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042782 10/06/2004 SEER MC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K092369 08/05/2009 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K093141 10/05/2009 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K073462 12/10/2007 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K092027 07/06/2009 CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K021135 04/09/2002 MODEL 2120IS SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K012718 08/15/2001 MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032582 08/21/2003 UNITY NETWORK PATIENT DATA SERVER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060661 03/13/2006 MACTRODE 3 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K073203 11/13/2007 CARESCAPE V100 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K030431 02/10/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K071073 04/16/2007 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031320 04/25/2003 EK-PRO ARRHYTHMIA DETECTION ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032370 08/01/2003 CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K120770 03/14/2012 QT GUARD PLUS ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K083639 12/09/2008 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032577 08/21/2003 MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033492 11/04/2003 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050614 03/10/2005 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050731 03/21/2005 SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060833 03/27/2006 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051026 04/22/2005 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K071982 07/19/2007 MODIFICATION TO: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042177 08/11/2004 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K062976 09/29/2006 MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K081437 05/22/2008 MAC 1600 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K964770 11/27/1996 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K955559 12/06/1995 COROMETRICS FETAL MOVEMENT DETECTION KIT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K962781 07/17/1996 COROMETRICS MODEL 510 AND 511 MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K102426 08/25/2010 CARESCAPE MODEL V100 VITAL SIGNS MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K082851 09/29/2008 MULTLINK CABLE AND LEADWIRE SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K040458 02/23/2004 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050583 03/07/2005 MODEL 250 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031376 05/01/2003 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K021435 05/06/2002 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022193 07/05/2002 DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032252 07/22/2003 MODEL 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022482 07/29/2002 SENSA-CUFF, MODELS INFANT, CHILD, ADULT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022834 08/26/2002 DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033304 10/14/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K072502 09/06/2007 MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060307 02/07/2006 12 RL ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K980756 02/27/1998 COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K993751 11/05/1999 COROMETRICS MODEL 173 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K083750 12/17/2008 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050093 01/14/2005 MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051518 06/08/2005 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K053356 12/02/2005 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K080157 01/23/2008 DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K020022 01/03/2002 DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K014255 12/26/2001 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K012915 08/30/2001 DINAMAP PRO 1000 MONITOR, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051367 05/25/2005 PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES


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