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

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

    K Number: K252805 · Decision Feb 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    14
    Review Days
    167

    Basic Information

    Device Name
    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
    K Number
    K252805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Received
    September 3, 2025
    Decision Date
    February 17, 2026
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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