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510(k) Data Aggregation

    K Number
    K191251
    Device Name
    Infared Thermometer
    Manufacturer
    Shenzhen Calibeur Industries Co., Ltd.
    Date Cleared
    2019-10-15

    (159 days)

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

    Shenzhen Calibeur Industries Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared thermometer 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 Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the forehead for clinical or home use. The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The measurement distance of the subject device is no more than 3cm. The Infrared thermometer included DT-8836T, DT-8836P. These two models are identical on hardware and software except the physical dimensions and appearance.
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