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510(k) Data Aggregation

    K Number
    K203656
    Device Name
    Non-Contact Forehead Thermometer (UT30H)
    Date Cleared
    2021-01-22

    (38 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: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.
    Device Description
    The Non-Contact Forehead Thermometer (Model: UT30H) is a hand-held, non-sterile, reusable, batteny 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 coverts 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. It 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 A AA batteries. The main functions of Non-Contact Forehead Thermometer are as followings: - Forehead measure function - Wide range of temperature readings: from 32.0℃ to 45.0℃(89.6℃ -113.0℃)) - The big LCD display showing clear measure result. - Low battery indicator
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