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

    COMPANION OXYGEN SAVER

    K Number: K863695 · Decision Oct 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    110
    Review Days
    23

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    Basic Information

    Device Name
    COMPANION OXYGEN SAVER
    K Number
    K863695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Puritan Bennett Corp.
    Date Received
    September 22, 1986
    Decision Date
    October 15, 1986
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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