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    K Number
    K122879
    Device Name
    EEGER4 MODEL 4.3
    Manufacturer
    EEG SOFTWARE LLC
    Date Cleared
    2013-02-06

    (140 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EEG SOFTWARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for general relaxation training when used with supported amplifier/encoders.
    Device Description
    This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data. The device processes EEG information, separates it into user-specified frequency bands, and displays the results as biofeedback indications to a user.
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