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510(k) Data Aggregation

    K Number
    K102719
    Device Name
    ATLANTEAN TRIGGER NEBULIZER
    Date Cleared
    2011-07-01

    (283 days)

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

    ATLANTEAN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
    Device Description
    The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used with a specific drug nor is it distributed with such drugs. The nebulizer has a trigger that allows the patient or clinician to activate the nebulizer which then generates respiratory size aerosolized liquids into gasses that are delivered directly to the patient This trigger function conserves medication and reduced environmental for breathing. contamination by medication. This nebulizer is also available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.
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