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510(k) Data Aggregation

    K Number
    K203331
    Device Name
    Quick-20m
    Manufacturer
    CGX, LLC
    Date Cleared
    2021-05-20

    (189 days)

    Product Code
    GWL, GXY
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    CGX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
    Device Description
    The Quick-20m is a wireless, battery-operated 10-20 montage EEG headset utilizing dry sensor technology. The headset provides an integrated approach to the wireless acquisition of EEG signals. A seated patient is free to exhibit natural movements while real-time data is collected. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise. The headset obtains high-quality EEG with minimal scalp preparation. Patented mechanisms and a range of replaceable dry sensors align to various head shapes and sizes, maintaining sensor positions in a standard 10-20 layout. EEG channels are digitized with 24 bits of resolution at 500 Hz. The Quick-20m is suitable for general-purpose EEG.
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