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510(k) Data Aggregation

    K Number
    K241160
    Device Name
    CAIs Sensor (CAIs-001)
    Manufacturer
    BrainU Co.,Ltd.
    Date Cleared
    2024-12-13

    (231 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BrainU Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
    Device Description
    The CAIs Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals. It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAIx and CAI software of CAI Monitoring System. The CAIs sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable. Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box. The hydrogel used in the sensors is designed for single use by one patient.
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