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510(k) Data Aggregation

    K Number
    K082657
    Device Name
    RTX RESPIRATOR
    Manufacturer
    MEDIVENT LIMITED
    Date Cleared
    2008-10-08

    (26 days)

    Product Code
    BYT
    Regulation Number
    868.5935
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVENT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Ventilation - The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange. 2) Secretion Clearance - Also for use in assisting patients with secretion clearance management as indicated by standard medical convention. The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.
    Device Description
    The RTX Respirator is an external high and low frequency respirator, which controls both phases of respiration. It consists of a lightweight flexible cuirass, tubing with a keypad and display screen. The Cuirass is available in eleven (11) sizes for various patient populations and sizes. The Cuirass contains a disposable seal and is attached to the patient via Velcro and nylon straps. The RTX Respirator ventilates by decreasing and then increasing the pressure within the cuirass. The negative pressure creates expansion of the chest bringing about inspiration. The positive phase creates positive pressure on the chest and therefore creates expiration.
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