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510(k) Data Aggregation

    K Number
    K981704
    Device Name
    AUREX-3
    Manufacturer
    ADM TRONICS UNLTD, INC.
    Date Cleared
    1998-08-05

    (83 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    K013253,K021202
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in treatment and control of tinnitus.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a tinnitus masker device called "Aurex-3". It does not contain information about acceptance criteria or a study proving device performance. The letter corrects a previous error regarding the device's classification (from OTC to prescription) and confirms its substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text. The document is strictly administrative in nature, concerning regulatory classification and marketing clearance, not technical performance or study data.

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