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

    PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT

    K Number: K880183 · Decision Apr 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT
    K Number
    K880183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Essex Cryogenics of Missouri, Inc.
    Date Received
    January 15, 1988
    Decision Date
    April 14, 1988
    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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    Other Clearances by Essex Cryogenics of Missouri, Inc.

    K Number Device Name
    K131990 OXYGEN GENERATOR LIQUEFIER - (OGL)
    K071581 BACKPACK MEDICAL OXYGEN SYSTEM
    K033000 NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
    K022684 PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)