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510(k) Data Aggregation

    K Number
    K972243
    Device Name
    2D VOG - VIDEO-OCULOGRAPHY
    Manufacturer
    SENSOMOTORIC INSTRUMENTS, GMBH
    Date Cleared
    1997-09-10

    (86 days)

    Product Code
    GWN, 84G
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENSOMOTORIC INSTRUMENTS, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.
    Device Description
    The 2D VOG measures horizontal and vertical eye movements and analyzes the eye movements for nystagmus beats and velocity. The results are visually displayed in different diagrams and are stored in a patient manager together with patient data. The device is intended to provide information for use by the health care professional, in conjunction with other clinically relevant information, in the diagnosis of vestibular disorders. The 2D VOG consists of a video camera mounted in a mask to record eye movements, an image processing board to digitize and analyze eye movement data, a video-overlay board and PC for real time display of eye movements, and software to analyze and display eye movement data. The system has a patient database for storage of patient data and results. The 2D VOG system software is used for nystagmus analysis during spontaneous nystagmus, caloric. smooth pursuit, optokinetic, rotation, positional, and saccadic examinations.
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