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

    AURAGEN CORTICAL SURFACE ELECTRODES

    K Number: K082250 · Decision Oct 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    AURAGEN CORTICAL SURFACE ELECTRODES
    K Number
    K082250
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Neurosciences
    Date Received
    August 8, 2008
    Decision Date
    October 10, 2008
    Product Code
    GYC
    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
    GYC Electrode, Cortical

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