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510(k) Data Aggregation

    K Number
    K103410
    Device Name
    NEOPAP SYSTEM
    Date Cleared
    2011-03-30

    (128 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHILDRENS MEDICAL VENTURES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeoPAP System is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat newborns and infants, weighing less than 5 kg, with RDS or who are recovering from RDS. (Respiratory Distress Syndrome).
    Device Description
    The Children's Medical Ventures LLC NeoPAP System provides nasal CPAP (continuous positive airway pressure) as a non-invasive method of breathing support for infants and newborns with compromised respiratory systems who weigh less than 5 kg. The NeoPAP System provides CPAP therapy delivered to patient through a nasal cannula or mask. The system has a feature called Baby-Trak which actively regulates pressure at all times by monitoring pressure at patient's nose and adjusting flow from oxygen and air gas supplies using proportional solenoids. The Baby-Trak feature eliminates the need for a closely-fitted patient interface that can damage fragile tissues. In addition to CPAP mode, the NeoPAP System offers a constant flow mode where the device delivers a fixed flow of humidified air/oxygen mixture through the nasal prongs or mask. There is also a resuscitation mode where the device delivers a fixed flow of unhumidified air/oxygen through the resuscitation port for use with a resuscitation or hyperinflation bag. The percentage of oxygen can be adjusted while in any mode by using a rotary knob on the user interface. The NeoPAP System alarms when pressure levels or oxygen concentration are above or below alarm limits. The system also detects occlusion, disconnect, and other alarm conditions. The system displays a real-time bar graph that indicates delivered pressure.
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