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510(k) Data Aggregation

    K Number
    K112564
    Device Name
    QUIXIE NEBULIZER
    Date Cleared
    2011-11-23

    (82 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODYSSEY MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quixie is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or healthcare professional. The intended environments for use include the home, hospitals, and clinics. The Quixie is intended for multiple use by a single patient.
    Device Description
    Not Found
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