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

    NeuroOne Cortical Electrode

    K Number: K192764 · Decision Nov 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    NeuroOne Cortical Electrode
    K Number
    K192764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuroone, Inc.
    Date Received
    September 30, 2019
    Decision Date
    November 26, 2019
    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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