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

    COMPASS CT STEREOTACTIC ADAPTATION SYSTEM

    K Number: K862220 · Decision Jun 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    5
    Review Days
    7

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    Basic Information

    Device Name
    COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
    K Number
    K862220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Stereotactic Medical Systems, Inc.
    Date Received
    June 11, 1986
    Decision Date
    June 18, 1986
    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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    Other Clearances by Stereotactic Medical Systems, Inc.

    K Number Device Name
    K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    K884415 EP-100 (SERIES)
    K883653 EP-100 INFUSION PUMP
    K871046 COMPASS STEREOTACTIC POSITIONING SYSTEM