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510(k) Data Aggregation

    K Number
    K082351
    Device Name
    NEPTUNE HYPERBARIC VENTILATOR
    Manufacturer
    LEVEL-5, INC.
    Date Cleared
    2009-01-02

    (140 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEVEL-5, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neptune Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.
    Device Description
    The Neptune Hyperbaric Ventilator consists of two main components: (1) a Control Module and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators and timing valves for control of inspiratory time, expiratory time, and inspiratory flow, as well as pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber and includes an exhalation valve, a pressure relief valye, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber door. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Neptune Hyperbaric Ventilator that are supplied with the device. Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
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