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

    EndoScreener

    K Number: K211326 · Decision Nov 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    EndoScreener
    K Number
    K211326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chengdu Wision Medical Device Co., Ltd.
    Date Received
    April 30, 2021
    Decision Date
    November 19, 2021
    Product Code
    QNP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNP Gastrointesinal Lesion Software Detection System

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