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

    Yikang Endotracheal Tube

    K Number: K190213 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    214

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    Basic Information

    Device Name
    Yikang Endotracheal Tube
    K Number
    K190213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangxi Yikang Medical Instrument Group Co., Ltd.
    Date Received
    February 4, 2019
    Decision Date
    September 6, 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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    Other Clearances by Jiangxi Yikang Medical Instrument Group Co., Ltd.

    K Number Device Name
    K173340 Yikang Latex Foley Catheter