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510(k) Data Aggregation

    K Number
    K202111
    Device Name
    Medical infrared forehead thermometer
    Date Cleared
    2021-02-26

    (211 days)

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

    Hunan Honggao Electronic Technolofy Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical infrared forehead thermometer (Model: HGO1, HGO1 V1, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.
    Device Description
    The proposed device. Medical infrared forehead thermometer, which includes model HGO1 VI, HGO6 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead of people aged over 1 year. The proposed devices measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display. The devices have the following features: About one-second measuring Body or Ambient temperature, 32-memory recalls, 9 and 9F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen, and the buzzer will tell the measurement has been completed. The device will display 3 different background colors according to the result. The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts: 2xAAA batteries, 1xManual and 1 pcs thermometer
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