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510(k) Data Aggregation

    K Number
    K982103
    Device Name
    ULMER (VNG) VIDEO NYSTAGMOGRAPH
    Manufacturer
    SYNAPSYS, INC.
    Date Cleared
    1998-09-11

    (88 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K070670,K163558
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations, i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests, and kinetic vestibular tests. The Ulmer VNG records and analyzes the bilateral, monocular, horizontal, and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by videocameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to a medical device consultant regarding the clearance of a device. It does not contain information about the acceptance criteria, study details, or performance data of the "Synapsys Ulmer Video Nystagmograph". Therefore, I cannot generate the requested table and information based on this input.

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