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510(k) Data Aggregation

    K Number
    K983851
    Device Name
    CAPELLA COCHLEAR EMISSIONS ANALYZER
    Manufacturer
    MADSEN ELECTRONICS, INC.
    Date Cleared
    1999-01-28

    (90 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

    Capella is designed to test cochlear function of both infants and adults in a hospital, nursery, ENT clinic or audiology office. It allows the operator to get information about a person's hearing without through or requiring any response from the individual being tested.

    Device Description

    Capella Cochlear Emissions Analyzer

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Madsen Electronics, Inc. regarding their Capella Cochlear Emissions Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices.

    The information needed to describe acceptance criteria and the study that proves the device meets those criteria is not present in the provided document. This document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.

    Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment.

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