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

    COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC

    K Number: K833484 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    83

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    Basic Information

    Device Name
    COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
    K Number
    K833484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    A. Patil, M.D.
    Date Received
    October 7, 1983
    Decision Date
    December 29, 1983
    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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