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    K Number
    K050313
    Device Name
    BIS SRS (SEMI-RESUABLE SENSOR)
    Manufacturer
    ASPECT MEDICAL SYSTEMS, INC.
    Date Cleared
    2005-02-24

    (15 days)

    Product Code
    GWY, GXY
    Regulation Number
    882.1750
    Why did this record match?
    Product Code :

    GWY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
    Device Description
    The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4 electrode array with a patented Zipprep design that is applied directly to the patient's forehead to record electro-physiological signals. The electrodes have a standard snap construction. There is an electronic smart card memory device in the multiple use cable. The SRS will be packaged as a set, composed of 100 disposable electrode arrays along with 1 multiple use cable.
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