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510(k) Data Aggregation

    K Number
    K142263
    Device Name
    Applanation Tonometer
    Manufacturer
    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
    Date Cleared
    2016-04-15

    (610 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The T170 Applanation Tonometer is indicated for Intraocular Pressure (IOP) measurement.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an Applanation Tonometer (K142263). It does not contain the acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device but does not detail the pre-clinical or clinical studies conducted by the manufacturer for this specific device.

    Therefore, I cannot provide the requested information based on the provided text. To answer your questions, the relevant sections of the 510(k) submission, specifically the performance data and testing summaries, would be required.

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