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

    Digital Thermometer, Model T28, T28L

    K Number: K232678 · Decision Jan 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    152

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    Basic Information

    Device Name
    Digital Thermometer, Model T28, T28L
    K Number
    K232678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guangdong Genial Technology Co., Ltd.
    Date Received
    September 1, 2023
    Decision Date
    January 31, 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 Guangdong Genial Technology Co., Ltd.

    K Number Device Name
    K240333 Wearable Digital Thermometer (T31)
    K231250 Digital Blood Pressure Monitor
    K231245 Digital Blood Pressure Monitor (Arm Type)
    K231243 Finger Clip Pulse Oximeter