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510(k) Data Aggregation

    K Number
    K162877
    Device Name
    VOCSN Unified Respiratory System
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Date Cleared
    2017-04-07

    (175 days)

    Product Code
    CBK, BTA, BZE, CAH, CAW, NHJ, NOU
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTEC LIFE SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.
    Device Description
    The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction. The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.
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