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510(k) Data Aggregation

    K Number
    K033146
    Device Name
    TONO-PEN TONOMETER TIP COVER
    Manufacturer
    TRA & ACCESSORIES
    Date Cleared
    2004-11-23

    (420 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.

    Device Description

    Tonometer Tip Covers

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Tono-Pen Tonometer Tip Cover." This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory clearance document, not a detailed study report.

    Therefore, I cannot provide the requested information based on the given text.

    To answer your request, I would need a different document, such as a study report, clinical trial results, or a more detailed section of the 510(k) submission that describes the testing and validation of the device.

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