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

    BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE

    K Number: K861435 · Decision Nov 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    20
    Review Days
    204

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    Basic Information

    Device Name
    BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE
    K Number
    K861435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The John Bunn Co.
    Date Received
    April 17, 1986
    Decision Date
    November 7, 1986
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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