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510(k) Data Aggregation

    K Number
    K990257
    Device Name
    KEELER PULSAIR 3000 NON CONTACT TONOMETER
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Date Cleared
    1999-03-25

    (57 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KEELER PULSAIR 3000 NON CONTACT TONOMETER

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

    Measurement of the Intraocular Pressure

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Keeler Pulsair 3000 Non Contact Tonometer. It generally confirms that the device is substantially equivalent to legally marketed predicate devices and states its intended use (measurement of Intraocular Pressure).

    However, the document does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for the device's performance. These details are typically found in the 510(k) submission itself or in separate scientific publications, not in the clearance letter.

    Therefore, I cannot provide the requested table and study details based solely on the given text.

    To answer your request, I would need access to the actual 510(k) submission for the Keeler Pulsair 3000 or a summary of its performance studies.

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