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

    GNOMOS STEREOTACTIC DEVICE

    K Number: K901670 · Decision Jul 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    GNOMOS STEREOTACTIC DEVICE
    K Number
    K901670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medical Equipment Development Co., Inc.
    Date Received
    April 10, 1990
    Decision Date
    July 3, 1990
    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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