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510(k) Data Aggregation

    K Number
    K974340
    Device Name
    UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
    Manufacturer
    UNITRON INDUSTRIES, INC.
    Date Cleared
    1997-12-12

    (24 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

    A. General Indications: 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). (Check appropriate space(s)): Severity: ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency -Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat

    Device Description

    Sound F/XP Programmble Mini BTE Hearing Aid

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a hearing aid device (Unitron Industries, Inc. Sound F/XP Programmable Mini BTE Hearing Aid).

    This document does not contain information related to acceptance criteria or a study proving device performance against acceptance criteria.

    The letter is primarily a regulatory approval document stating that the device is "substantially equivalent" to legally marketed predicate devices for specific indications of use. It outlines general compliance requirements, potential future concerns regarding electromagnetic interference, and contact information for regulatory advice.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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