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510(k) Data Aggregation

    K Number
    K093006
    Device Name
    FONIX ,MODEL 8000
    Manufacturer
    FRYE ELECTRONICS, INC.
    Date Cleared
    2009-12-30

    (93 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 8000

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

    This device performs electro-acoustical, telecoil, and battery current measurements of hearing aids.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the FONIX 8000 Hearing Aid Test System, which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls but does not include details on specific acceptance criteria, study methodologies, or performance results.

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