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

    SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE

    K Number: K851659 · Decision Jul 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    8
    Review Days
    69

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    Basic Information

    Device Name
    SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
    K Number
    K851659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medco Products, Co., Inc.
    Date Received
    April 23, 1985
    Decision Date
    July 1, 1985
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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