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    K Number
    K192764
    Device Name
    NeuroOne Cortical Electrode
    Manufacturer
    NeuroOne, Inc.
    Date Cleared
    2019-11-26

    (57 days)

    Product Code
    GYC
    Regulation Number
    882.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroOne, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.
    Device Description
    The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (< 30 days) on the surface of the brain. The electrodes are designed to record and/or monitor the brain's electrical activity as well as stimulate the brain. It consists of a series of contacts mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The device is connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other cortical electrodes, including the predicate device.
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