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

    OXYGEN GENERATOR LIQUEFIER - (OGL)

    K Number: K131990 · Decision Feb 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    5
    Review Days
    238

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    Basic Information

    Device Name
    OXYGEN GENERATOR LIQUEFIER - (OGL)
    K Number
    K131990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Essex Cryogenics of Missouri, Inc.
    Date Received
    June 28, 2013
    Decision Date
    February 21, 2014
    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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    Other Clearances by Essex Cryogenics of Missouri, Inc.

    K Number Device Name
    K071581 BACKPACK MEDICAL OXYGEN SYSTEM
    K033000 NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
    K022684 PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
    K880183 PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT