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General Electric Medical Systems Information Techn

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTIONDecember 3, 2002
K021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDERNovember 14, 2002
K023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTSOctober 11, 2002
K021454UNITY NETWORK IDOctober 1, 2002
K020290DASH 3000/4000 PATIENT MONITORAugust 14, 2002
K021366MAC-LAB/CARDIOLAB EP/COMBOLABJuly 3, 2002
K020661UNITY IS PATIENT VIEWERMay 24, 2002
K021325MODIFICATION OF APEXPRO TELEMETRY SYSTEMMay 7, 2002
K020524PATIENTNET MONITORING SYSTEMMarch 20, 2002
K012467SOLAR 8000M SYSTEMFebruary 11, 2002
K014108MAC 5000 ECG ANALYSIS SYSTEMJanuary 10, 2002
K012466BIS/EEG MODULEOctober 1, 2001
K011000TRAM 2001 MODULEJune 29, 2001
K010164ICG MODULEApril 9, 2001
K002957SOLAR SPO2 MODULE WITH MASIMO SETOctober 18, 2000
K002209GE MARQUETTE ECG ANALYSIS PROGRAMAugust 18, 2000
K001359DASH 3000/4000 PATIENT MONITORJuly 18, 2000
K001268GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONSJuly 17, 2000
K001305MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEMJune 27, 2000
K001112GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CICJune 14, 2000