BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN

    K Number: K933161 · Decision Oct 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    28
    Review Days
    100

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    Basic Information

    Device Name
    ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
    K Number
    K933161
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dupont Medical Products
    Date Received
    June 29, 1993
    Decision Date
    October 7, 1993
    Product Code
    EAM
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EAM Screen, Intensifying, Radiographic

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