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

    OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400

    K Number: K913121 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    30
    Applicant Total
    27
    Review Days
    31

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    Basic Information

    Device Name
    OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400
    K Number
    K913121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Continental X-Ray Corp.
    Date Received
    July 16, 1991
    Decision Date
    August 16, 1991
    Product Code
    KXJ
    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
    KXJ Table, Radiologic

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