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

    C.B. RADIOLOGY DESIGN GONADSHIELD

    K Number: K833523 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    C.B. RADIOLOGY DESIGN GONADSHIELD
    K Number
    K833523
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radiology Design
    Date Received
    September 20, 1983
    Decision Date
    November 21, 1983
    Product Code
    IWT
    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
    IWT Shield, Gonadal

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