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510(k) Data Aggregation

    K Number
    K201536
    Device Name
    Infrared Forehead Thermometer
    Date Cleared
    2021-02-10

    (247 days)

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

    Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages.
    Device Description
    The infrared forehead thermometer, Model of QY-EWQ-02 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home. The infrared forehead thermometer has the following features: 1) This device can be used for measuring the forehead temperature; 2) Body and object temperature switching 3) Two temperature unit conversion, °C or °F; 4) LCD display with backlight; 5) Automatic range selection; resolution is 0.1℃ (0.1℃F) 6) The latest 20 measurement data can be memorized and stored; Three color backlight display (Red, Orange, Green); 7) 8) Low battery detection; Turn on/off the prompt tone; 9) 10) High temperature alarm limit setting; 11) Ambient temperature detection; 12) Malfunction indication; 13) Low and high temperature alarm
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