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510(k) Data Aggregation

    K Number
    K961653
    Device Name
    PHONAK SONA P2
    Manufacturer
    PHONAK, INC.
    Date Cleared
    1996-05-29

    (29 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    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

    To amplify and transmit sound to the ear

    Device Description

    Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments

    AI/ML Overview

    The provided text describes a hearing instrument, the Phonak Sona P2. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot fulfill your request as the necessary information is not present in the input. The exhibit only provides a summary of the device's characteristics and intended use.

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