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510(k) Data Aggregation

    K Number
    K990869
    Device Name
    LEICA AT550
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Date Cleared
    1999-06-07

    (83 days)

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

    LEICA AT550

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

    The AT550 is intended to measure intraocular pressure of the eye.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the Leica AT550 Non-contact Tonometer. It primarily addresses the regulatory approval process and states the device's intended use. However, it does not include information on acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications as requested. This document is a regulatory communication, not a clinical study report. Therefore, I cannot generate the requested table and study details based solely on the provided text.

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