BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EZ-OX PLUS GENERATION II

    K Number: K131386 · Decision Mar 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    304

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    Basic Information

    Device Name
    EZ-OX PLUS GENERATION II
    K Number
    K131386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Air Liquide Healthcare America
    Date Received
    May 14, 2013
    Decision Date
    March 14, 2014
    Product Code
    ECX
    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
    ECX Cylinder, Compressed Gas, And Valve

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    Other Clearances by Air Liquide Healthcare America

    K Number Device Name
    K053117 EZ-OX PLUS