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510(k) Data Aggregation

    K Number
    K070670
    Device Name
    EYETRACKER/IDEAS
    Date Cleared
    2007-09-18

    (190 days)

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

    S.A. INSTRUMENTATION DIFRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function. The device is for prescription use only and it 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 device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.
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