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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?
    Product Code :

    BYT

    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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    K Number
    K072290
    Device Name
    PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
    Manufacturer
    DIMA ITALIA SRL
    Date Cleared
    2008-05-29

    (287 days)

    Product Code
    BYT
    Regulation Number
    868.5935
    Why did this record match?
    Product Code :

    BYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).
    Device Description
    The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work with a cuirass, poncho, or a ventilating chamber (Porta-Lung). An optional Trigger can be installed, sensing the spontaneous demands of the patient and permitting the use in Synchro/Timed, Spontaneous/Timed and Spontaneous with Plateau modes. If the Triggers are installed, the Autoparameters Function is enabled too, permitting the evaluation of the Respiratory Frequency and I/E Ratio of the patient in automatic mode. The negative pressure ventilation is a mechanical kind of ventilation similar to the human spontaneous ventilation. The Pegaso V is designed around a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient. The blower takes air from the atmosphere, compresses it in order to generate a pressure/depressure controlled by electronic sensors. Leaks are compensated cycle by cycle. The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the compressed flow go toward the patient and the depressed flow toward the atmosphere or, instead, the compressed flow to the atmosphere and the depressed flow toward the patient. The working parameters are displayed on an LCD and controlled through a touch keyboard.
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