BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    OBT STEREOTACTIC SYSTEM

    K Number: K874693 · Decision Mar 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    127

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    Basic Information

    Device Name
    OBT STEREOTACTIC SYSTEM
    K Number
    K874693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tipal Instruments , Ltd.
    Date Received
    November 5, 1987
    Decision Date
    March 11, 1988
    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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