BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Imaging, Fluorescence

    PMA: P020008 · Supplement: S002 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Imaging, Fluorescence
    Trade Name
    KARL STORZ AUTOFLUORESCENCE SYSTEM
    PMA Number
    P020008
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MRK
    Generic Name
    SYSTEM, IMAGING, FLUORESCENCE
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2009
    Date Received
    October 22, 2009
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPLACEMENT OF THE KARL STORZ CAMERA CONTROL UNIT (CCU), TRICAM SL (ANALOG PROCESSING) WITH THE TRICAM SL II (DIGITAL SIGNAL PROCESSING).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRK System, Imaging, Fluorescence