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    K Number
    K111308
    Device Name
    ZYTO HAND CRADLE
    Manufacturer
    ZYTO TECHNOLOGIES, INC
    Date Cleared
    2011-08-30

    (112 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYTO TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The measurement of Galvanic Skin Response
    Device Description
    The ZYTO Hand Cradle is a Galvanic Skin Response Measurement Device. The device is designed, owned, manufactured, and distributed by ZYTO Technologies, Inc. The device consists of electrical circuit boards encased in a plastic/metal case. The device is non-invasive and comes in contact with the patient via conductive contacts (the equivalent of a stylus and hand-mass) incorporated into one piece, using the same functionality as the predicate device. The device connects to a computer to supply data to an operator.
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