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

    DUOCEPH

    K Number: K864527 · Decision Jan 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    DUOCEPH
    K Number
    K864527
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1920
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Gary E. Hall, Dds
    Date Received
    November 17, 1986
    Decision Date
    January 7, 1987
    Product Code
    IWY
    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
    IWY Holder, Head, Radiographic

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