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510(k) Data Aggregation

    K Number
    DEN140024
    Device Name
    cNEP Airway
    Manufacturer
    Date Cleared
    2015-12-23

    (492 days)

    Product Code
    Regulation Number
    868.5105
    Why did this record match?
    Product Code :

    PMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The cNEP Airway Management System is to be used as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.
    Device Description
    The cNEP Airway Management System is a silicone rubber collar that is attached to the neck by a hydrogel and provides negative suction through a regulated vacuum source (see Figure 1). The vacuum suction allows the device to provide a patent airway during mild to moderate sedation.
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