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510(k) Data Aggregation

    K Number
    K973377
    Device Name
    SIBELMED AC50D
    Manufacturer
    TRUTONE
    Date Cleared
    1998-03-10

    (183 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

    Device Description

    It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

    AI/ML Overview

    This request cannot be fulfilled. The provided text is a truncated FDA 510(k) clearance letter for an audiometer. It does not contain any information regarding acceptance criteria, study design, or performance data for the device. Therefore, I cannot extract the requested information to describe the acceptance criteria and the study that proves the device meets them.

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