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510(k) Data Aggregation

    K Number
    K992473
    Device Name
    EXPRESSEYE
    Date Cleared
    1999-08-12

    (17 days)

    Product Code
    Regulation Number
    882.1460
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    Applicant Name (Manufacturer) :

    OPTOMOTOR LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ExpressEye is used to measure the saccadic movements of the eye and classify a subject's performance in different tasks as normal or abnormal. Subjects are patients above the age of 6 years with suspicion of problems in dynamic vision and/or optomotor control. ExpressEye can be used in any case of problems in the optomotor domain. The measured horizontal eye movements of a person made in response to generated stimuli are analysed to nontonial cyc inovential or a person's fixation and reflexive and voluntary eye movement control.
    Device Description
    ExpressEye measures horizontal eye movements and analyses the fixation quality, direction and reaction time of fast eye movements. The device consists of a head band, which carries light sources for visual stimuli, an amplifier, and infrared light emmitting/receiving elements. A hand held processor controls the stimuli and analyses the eye movement signals. Optional the user can transfer the data to a personal computer.
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