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

    MARK III OXYGEN WALKER SYSTEM

    K Number: K820836 · Decision Apr 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    69
    Review Days
    20

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    Basic Information

    Device Name
    MARK III OXYGEN WALKER SYSTEM
    K Number
    K820836
    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 26, 1982
    Decision Date
    April 15, 1982
    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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