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510(k) Data Aggregation

    K Number
    K163277
    Device Name
    SuperNO2VA Device
    Date Cleared
    2017-10-13

    (326 days)

    Product Code
    Regulation Number
    868.5550
    Why did this record match?
    Product Code :

    BSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SuperNOsY A™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the continum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure. The SuperNOsVA™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.) It is a single patient use, disposable. The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.
    Device Description
    The SuperNO>VA™ is a 2-piece construction with a nasal and an oral portion. When assembled together the oral portion is connected to the nasal portion (chamber) contains 2 one way (duck bill) valves which are normally closed until the oral chamber is connected. Then gas passes through each portion to the patient. If one desires to remove the oral chamber during a procedure which requires oral access, then gas can still be provided via the nasal portion. Depending upon the equipment and the clinician's desire one can provide non-invasive positive pressure ventilation as well.
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