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    K Number
    K183437
    Device Name
    AirRay Subdural Cortical Electrodes
    Manufacturer
    CorTec GmbH
    Date Cleared
    2019-03-12

    (90 days)

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

    CorTec GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
    Device Description
    The ° AirRay® Subdural Cortical Electrodes Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
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