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510(k) Data Aggregation

    K Number
    K082345
    Device Name
    OXYGEN DEMAND VALVE
    Manufacturer
    BPR MEDICAL, LTD.
    Date Cleared
    2009-03-13

    (210 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    BPR MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carnét Oxygen Demand Valve is intended to be used for the delivery of 100% oxygen in response to the patient's inspiratory effort on the order of a physician. This product is designed for use with adult and paediatric patients in hospitals, ambulances or other managed clinical environments. This product is not intended to be used with infants or neonates.
    Device Description
    Oxygen Demand Valve
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