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510(k) Data Aggregation

    K Number
    K980505
    Device Name
    HORTMANN AMDIS-OAE OAE ANALYZER
    Manufacturer
    HORTMANN AG
    Date Cleared
    1998-04-07

    (57 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    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

    Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device. It is an FDA 510(k) clearance letter for the Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer, stating that the device is substantially equivalent to legally marketed predicate devices and outlining its indications for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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