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    K Number
    K032967
    Device Name
    PASCAL DYNAMIC CONTOUR TONOMETER
    Manufacturer
    SMT SWISS MICROTECHNOLOGY AG
    Date Cleared
    2003-11-14

    (52 days)

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

    PASCAL DYNAMIC CONTOUR TONOMETER

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

    The PASCAL™ Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations. PASCAL™ is specially indicated in Glaucoma.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a tonometer, which details the regulatory approval of the device. It does not include information about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a study proving device performance.

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