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510(k) Data Aggregation

    K Number
    K202440
    Device Name
    Infrared Thermometer
    Date Cleared
    2021-06-17

    (296 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Sonida Digital Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
    Device Description
    HT series infrared thermometers (includes model HT-101, HT-102, HT-103 and HT-104) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. These thermometers have the following features: - The device is intended to be used by consumers in the household environments and by healthcare providers; - The device is mainly composed of infrared sensor, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries; - It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer; - Switching between Celsius and Fahrenheit; - Multi-functional, can measure ear and forehead temperature; - Automatic range selection; resolution is 0.1 Celsius (0.1 Fahrenheit); - The latest 35 measurement data can be memorized and stored; the user can view the previous measurement results; - High temperature alarm function, displayed in green, orange and red backlight; - Switching between mute and un-mute mode; - Low battery indication, and auto shut-down.
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