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510(k) Data Aggregation

    K Number
    K972122
    Device Name
    DREAM CATCHER
    Date Cleared
    1997-08-29

    (85 days)

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

    REST TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires, intended for use during various types of EEG testing in which only a subset of the full 10/20 electrode sites are required. This cap is NOT intended for use in which a full set of the 10/20 electrode positions need to be monitored, or in which precise localization of the EEG activity is of vital importance such as localization of a seizure focus. The Dream Catcher holds electrodes at the C3, Cz, C4, O1, OZ, O2, A1 and A2 positions.
    Device Description
    The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires.
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