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

    LINDE MARK II OXYGEN RESERV. TYPE OR-4

    K Number: K810732 · Decision Mar 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    69
    Review Days
    10

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    Basic Information

    Device Name
    LINDE MARK II OXYGEN RESERV. TYPE OR-4
    K Number
    K810732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Union Carbide Corp.
    Date Received
    March 17, 1981
    Decision Date
    March 27, 1981
    Product Code
    BYJ
    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
    BYJ Unit, Liquid-Oxygen, Portable

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