BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Imaging, Fluorescence

    PMA: P950042 · Decision Sep 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Imaging, Fluorescence
    Trade Name
    PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
    PMA Number
    P950042
    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
    September 19, 1996
    Date Received
    December 22, 1995
    Expedited Review
    N
    Docket Number
    97M-0122

    Advisory Committee Statement

    APPROVAL FOR THE XILLIX LIFE-LUNG FLUORESCENCE ENDOSCOPY SYSTEM

    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