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

    MICROVISION FAST DETAIL INTENSIFYING SCREEN

    K Number: K931283 · Decision Jun 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    253
    Review Days
    88

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    Basic Information

    Device Name
    MICROVISION FAST DETAIL INTENSIFYING SCREEN
    K Number
    K931283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 12, 1993
    Decision Date
    June 8, 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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