FDA 510(k) Applications Submitted by GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

FDA 510(k) Number Submission Date Device Name Applicant
K000779 03/10/2000 APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K001112 04/06/2000 GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K001268 04/20/2000 GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K001359 04/28/2000 DASH 3000/4000 PATIENT MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991735 05/21/1999 MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K992929 08/31/1999 DASH 3000 PATIENT MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K002957 09/22/2000 SOLAR SPO2 MODULE WITH MASIMO SET GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K023380 10/08/2002 T-WAVE ALTERMANS (TWA) ALGORITHM OPTION GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K020524 02/19/2002 PATIENTNET MONITORING SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K000645 02/25/2000 GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K001305 04/24/2000 MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K021325 04/26/2002 MODIFICATION OF APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K021454 05/06/2002 UNITY NETWORK ID GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K990068 01/08/1999 SOLAR 9500 INFORMATION MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K010164 01/18/2001 ICG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K020290 01/28/2002 DASH 3000/4000 PATIENT MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K020661 03/01/2002 UNITY IS PATIENT VIEWER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K011000 04/03/2001 TRAM 2001 MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K012466 08/01/2001 BIS/EEG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K012467 08/01/2001 SOLAR 8000M SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K993757 11/05/1999 SOLAR 7/8000 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K994430 12/29/1999 IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K002209 07/21/2000 GE MARQUETTE ECG ANALYSIS PROGRAM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991014 03/26/1999 CASE 8000 EXERCISE TESTING SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991786 05/25/1999 MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K992637 08/06/1999 MUSE CARDIOVASCULAR INFORMATION SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K021366 04/30/2002 MAC-LAB/CARDIOLAB EP/COMBOLAB GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K021470 05/08/2002 SEER LIGHT COMPACT DIGITAL HOLTER RECORDER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K023100 09/18/2002 ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K014108 12/13/2001 MAC 5000 ECG ANALYSIS SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K992948 08/31/1999 MAC-LAB SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991739 05/21/1999 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991905 06/04/1999 COROMETRICS MODEL 171 AND 172 FETAL MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN


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