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

    NEURODRIVE SYSTEM

    K Number: K051830 · Decision Sep 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    4
    Review Days
    72

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    Basic Information

    Device Name
    NEURODRIVE SYSTEM
    K Number
    K051830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alpha Omega , Ltd.
    Date Received
    July 6, 2005
    Decision Date
    September 16, 2005
    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
    K013396 ALPHA DRIVE SYSTEM
    K993622 NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY