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510(k) Data Aggregation

    K Number
    K981841
    Device Name
    BREATHE EASY, MODELS AD AND CD
    Manufacturer
    RESPIRAID LTD.
    Date Cleared
    1998-10-13

    (140 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRAID LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
    Device Description
    The BREATHE EASY is an adjustable, personal system for treating air in a specified area of a room. The BREATHE EASY device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter, for removing contaminants from the air flowing along the flow path. The BREATHE EASY Model AD device contains also an air filtering system with a heater and humidifier for treating ambient air so as to bring it to a preselected respiratory comfort level. The BREATHE EASY device provides a method for guiding the treated air outflow so as to obtain a flow distribution in close proximity to the head of a user, thereby forming a treated air envelope surrounding his respiratory openings. The BREATHE EASY device is supported on an adjustable support arm, adjustably mounted onto a household furniture (e.g., bed), wall, or wheeled support structure.
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