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510(k) Data Aggregation

    K Number
    K992835
    Device Name
    C.S.O. TONOMETER
    Manufacturer
    CSO
    Date Cleared
    2000-06-06

    (288 days)

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

    C.S.O. TONOMETER

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

    A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).

    Device Description

    A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).

    AI/ML Overview

    This is a 510(k) clearance letter for a medical device (C.S.O. Tonometer) and does not contain detailed information about the acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for FDA 510(k) clearance. However, it does not provide the specific performance criteria or the results of a study to demonstrate that the device meets those criteria.

    To answer your questions, I would need a detailed study report, a submission summary, or a similar technical document that describes the device's testing and performance.

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