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

    COPD LIQUID OXYGEN PORTABLE, MODEL 300P

    K Number: K072011 · Decision Oct 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    COPD LIQUID OXYGEN PORTABLE, MODEL 300P
    K Number
    K072011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copd Partners, Inc.
    Date Received
    July 23, 2007
    Decision Date
    October 18, 2007
    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 Copd Partners, Inc.

    K Number Device Name
    K071461 MODEL 300D HOME OXYGEN LIQUEFIER