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510(k) Data Aggregation

    K Number
    K973579
    Device Name
    AM SERIES HEARING AID
    Manufacturer
    A & M HEARING, LTD.
    Date Cleared
    1997-10-28

    (39 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

    The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification document from the FDA, primarily discussing the substantial equivalence of various models of AM Hearing Limited hearing aids to previously marketed devices. It lists general and specific indications for use for these devices.

    However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document and not a technical performance report.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided input.

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