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510(k) Data Aggregation

    K Number
    K092089
    Device Name
    CLARUJUST
    Manufacturer
    AUDIGENCE, INC.
    Date Cleared
    2010-03-10

    (244 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

    Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers. Clarujust™ is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

    Device Description

    Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Audigence Clarujust™ does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets those criteria. The letter is a notification of substantial equivalence for marketing the device and details regulatory requirements, but it does not include performance data or study specifics.

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