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510(k) Data Aggregation

    K Number
    K062015
    Device Name
    CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
    Manufacturer
    Date Cleared
    2006-10-31

    (106 days)

    Product Code
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRONOS VISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
    Device Description
    The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions. The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
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