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

    REGULUS NAVIGATOR

    K Number: K964229 · Decision Aug 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    2
    Review Days
    300

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    Basic Information

    Device Name
    REGULUS NAVIGATOR
    K Number
    K964229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compass Intl., Inc.
    Date Received
    October 23, 1996
    Decision Date
    August 19, 1997
    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 Compass Intl., Inc.

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    K935456 REGULUS MEASUREMENT UNIT