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510(k) Data Aggregation

    K Number
    K980377
    Device Name
    FONIX FP35 HEARING AID ANALYZER
    Manufacturer
    FRYE ELECTRONICS, INC.
    Date Cleared
    1998-03-18

    (44 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FONIX FP35 HEARING AID ANALYZER

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

    The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient.

    If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.

    Device Description

    Fonix FP35 Hearing Aid Analyzer

    AI/ML Overview

    This is a 510(k) clearance letter and an Indications for Use statement for the "Fonix FP35 Hearing Aid Analyzer." The provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.

    Therefore, I cannot fulfill your request for the information outlined in your prompt, as it is not present in the provided text.

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