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

    ULTRAMAXO2 OXYGEN ANALYER

    K Number: K112402 · Decision Dec 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    119
    Applicant Total
    2
    Review Days
    114

    Basic Information

    Device Name
    ULTRAMAXO2 OXYGEN ANALYER
    K Number
    K112402
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MAXTEC, LLC
    Date Received
    August 22, 2011
    Decision Date
    December 14, 2011
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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