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

    Digital Thermometer (Model QT001)

    K Number: K223044 · Decision May 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    223

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    Basic Information

    Device Name
    Digital Thermometer (Model QT001)
    K Number
    K223044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shen Zhen Rong Feng Technology Co., Ltd.
    Date Received
    September 29, 2022
    Decision Date
    May 10, 2023
    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 Shen Zhen Rong Feng Technology Co., Ltd.

    K Number Device Name
    K223037 Infrared Thermometer, Model: IR8807