BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OXYGEN DEMAND VALVE

    K Number: K082345 · Decision Mar 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    OXYGEN DEMAND VALVE
    K Number
    K082345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bpr Medical, Ltd.
    Date Received
    August 15, 2008
    Decision Date
    March 13, 2009
    Product Code
    CBP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBP Valve, Non-Rebreathing

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    Other Clearances by Bpr Medical, Ltd.

    K Number Device Name
    K943797 BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER