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

    AirLife Infant Single Limb Heated Wire Circuit

    K Number: K151959 · Decision Jan 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    3
    Review Days
    188

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    Basic Information

    Device Name
    AirLife Infant Single Limb Heated Wire Circuit
    K Number
    K151959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion, Inc.
    Date Received
    July 16, 2015
    Decision Date
    January 20, 2016
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Carefusion, Inc.

    K Number Device Name
    K193088 MaxZero Extension Sets with Needle-Free Connector(s)
    K153234 AirLife Adult Heated Wire Circuit