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510(k) Data Aggregation

    K Number
    K964646
    Device Name
    VIDEO EYE TRAKKER
    Manufacturer
    MICROMEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-07-15

    (237 days)

    Product Code
    GWN,84G
    Regulation Number
    882.1460
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIDEO EYE TRAKKER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a paysiologic signal amplifier for monitoring eye position.

    Device Description

    Video Eye Trakker

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is an FDA 510(k) clearance letter for the "Video Eye Trakker" device, confirming its substantial equivalence to previously marketed devices. It outlines regulatory information and contact details but does not include any technical or performance study data.

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