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510(k) Data Aggregation

    K Number
    K092263
    Device Name
    ENDURAVENT-5 VENTILATOR
    Manufacturer
    PROVIDENCE GLOBAL MEDICAL, INC.
    Date Cleared
    2010-01-21

    (177 days)

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

    PROVIDENCE GLOBAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.
    Device Description
    The EnduraVent-5 Ventilator is a self-contained, portable ventilator, consisting totally of non-magnetic components which include: (10 a gas inlet connector, (2) a gas inlet filter, (3) two timing valves, (4) a pilot actuator valve, (5) a flow metering valve, and, (6) a pressure-relief valve. During the inspiratory time phase of the system, a small portion of the gas flowing through the system is diverted to the exhalation valve diaphragm, inflating the diaphragm in sequence with the inspiratory time, thereby allowing the main gas flow from the Device to flow to the patient. During the expiratory phase, all ventilator gas flow ceases, the exhalation valve opens and the patients's exhaled gases flow to atmosphere.
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    K Number
    K092264
    Device Name
    ATLANTIS HYPERBARIC CHAMBER VENTILATOR
    Manufacturer
    PROVIDENCE GLOBAL MEDICAL, INC.
    Date Cleared
    2009-12-17

    (142 days)

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

    PROVIDENCE GLOBAL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.
    Device Description
    The Atlantis 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, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and 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 valve, 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 bulkhead. 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 Atlantis Hyperbaric Ventilator, and 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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