BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Endotracheal tube; Reinforced Endotracheal tube

    K Number: K170234 · Decision Jan 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    357

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    Basic Information

    Device Name
    Endotracheal tube; Reinforced Endotracheal tube
    K Number
    K170234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhanjiang Star Enterprise Co., Ltd.
    Date Received
    January 25, 2017
    Decision Date
    January 17, 2018
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Zhanjiang Star Enterprise Co., Ltd.

    K Number Device Name
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