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510(k) Data Aggregation

    K Number
    K040996
    Device Name
    RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
    Manufacturer
    GYRUS ENT L.L.C.
    Date Cleared
    2004-08-20

    (126 days)

    Product Code
    NIX
    Regulation Number
    874.3950
    Why did this record match?
    Product Code :

    NIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mild to moderate high frequency hearing loss .
    Device Description
    The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.
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    K Number
    DEN020003
    Device Name
    RETROX
    Manufacturer
    AURIC HEARING SYSTEMS, INC.
    Date Cleared
    2002-08-20

    (60 days)

    Product Code
    NIX
    Regulation Number
    874.3950
    Why did this record match?
    Product Code :

    NIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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