BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Endotracheal Tube with Evacuation Lumen

    K Number: K182739 · Decision Dec 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    17
    Review Days
    439

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    Basic Information

    Device Name
    Endotracheal Tube with Evacuation Lumen
    K Number
    K182739
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Well Lead Medical Co., Ltd.
    Date Received
    September 28, 2018
    Decision Date
    December 11, 2019
    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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