BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

    K Number: K081516 · Decision Aug 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
    K Number
    K081516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medsource International, LLC
    Date Received
    May 30, 2008
    Decision Date
    August 26, 2008
    Product Code
    CBP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    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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