LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022510
    Device Name
    FONIX, MODEL 7000
    Manufacturer
    FRYE ELECTRONICS, INC.
    Date Cleared
    2002-08-27

    (28 days)

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

    FONIX, MODEL 7000

    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 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.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter for the Fonix, Model 7000 hearing aid calibrator and analysis system, indicating that the FDA has found it substantially equivalent to a legally marketed predicate device. It briefly mentions the device's indications for use but does not delve into detailed performance metrics or studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1