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

    Infrared Thermometer: Model YJ600

    K Number: K232473 · Decision Feb 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    177

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    Basic Information

    Device Name
    Infrared Thermometer: Model YJ600
    K Number
    K232473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhuhai Yueja Medical Device Technology Co., Ltd.
    Date Received
    August 16, 2023
    Decision Date
    February 9, 2024
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Zhuhai Yueja Medical Device Technology Co., Ltd.

    K Number Device Name
    K232815 Wrist Blood Pressure Monitor
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