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    K Number
    K202368
    Device Name
    Infrared Thermometer
    Manufacturer
    Shandong Bittel Intelligent Technology Co., Ltd.
    Date Cleared
    2021-02-12

    (177 days)

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

    Shandong Bittel Intelligent Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared thermometer is non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use
    Device Description
    The proposed device, infrared thermometer, is hand-held, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 1~5cm. The device is non-contacting infrared thermometer and intended for people of all age.
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