BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

    K Number: K053356 · Decision Apr 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    136
    Review Days
    138

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    Basic Information

    Device Name
    MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
    K Number
    K053356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    December 2, 2005
    Decision Date
    April 19, 2006
    Product Code
    DXJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXJ Display, Cathode-Ray Tube, Medical

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