BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

    K Number: K993622 · Decision Jan 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
    K Number
    K993622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Omega , Ltd.
    Date Received
    October 26, 1999
    Decision Date
    January 24, 2000
    Product Code
    GZL
    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
    GZL Electrode, Depth

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    Other Clearances by Alpha Omega , Ltd.

    K Number Device Name
    K071697 NEURONAV SYSTEM AND NEURONAV DRIVE
    K051830 NEURODRIVE SYSTEM
    K013396 ALPHA DRIVE SYSTEM