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510(k) Data Aggregation

    K Number
    K012415
    Device Name
    AURIS AEP
    Manufacturer
    SYNAPSYS, INC.
    Date Cleared
    2001-12-18

    (141 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is ittended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Auris AEP" (later referred to as "AURIS I and AURIS II ABR Systems"). It establishes substantial equivalence to a predicate device and outlines regulatory guidelines.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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