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510(k) Data Aggregation

    K Number
    K013259
    Device Name
    PORTABLE NON-CONTACT TONOMETER, MODEL PT100
    Manufacturer
    LEICA MICROSYSTEMS, INC. O.I.D.
    Date Cleared
    2002-02-20

    (142 days)

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

    PORTABLE NON-CONTACT TONOMETER, MODEL PT100

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

    The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Reichert PT100 Portable Tonometer. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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

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