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510(k) Data Aggregation

    K Number
    K203747
    Device Name
    Non-Contact Forehead Thermometer (Models UT306H & UT308H)
    Date Cleared
    2021-01-25

    (34 days)

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

    Uni-Trend Technology (China) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
    Device Description
    The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a hand-held, nonsterile, reusable, battery powered device designed to measure human body temperature wa body sites: the skin of the forehead. The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that converts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings. lt is composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover. The power supply of the thermometer are 3.0V DC, it is supplied by two AA batteries. The main functions of Non-Contact Forehead Thermometer are as follows: - Forehead measurement functions - Wide range of temperature readings: from 32.0℃ to 45.0℃ (89.6℃ -113.0℃ ) - The big LCD display showing clear measurement results. - Memory function - Low battery indicator
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