BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NAVIGATION MARKER, REFLECTIVE MARKER SPHERES

    K Number: K103192 · Decision Feb 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    101

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    Basic Information

    Device Name
    NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
    K Number
    K103192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ilumark GmbH
    Date Received
    October 29, 2010
    Decision Date
    February 7, 2011
    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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