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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUDIGENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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