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510(k) Data Aggregation

    K Number
    K223037
    Device Name
    Infrared Thermometer, Model: IR8807
    Manufacturer
    Shen Zhen Rong Feng Technology Co., Ltd
    Date Cleared
    2023-07-21

    (295 days)

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

    Shen Zhen Rong Feng Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.
    Device Description
    The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode. The Infrared Thermometer (Model: IR8807), consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuitry c) Erasable Programmable Read-Only Memory Integrated Circuit d) Capacitance-touch Integrated Circuit e) LCD display f) 2 buttons (Scan button, Setting button,) q) 2×1.5V AAA dry batteries The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode. The main functions of Infrared Thermometer (Model: IR8807) are as followings: Forehead temperature measure functions Wide range of temperature readings: from 32.0ºCto 42.9ºC (89.6ºF ~ 109.2ºF) The measurement results can be displayed in either °Cor °F units The LCD display showing clear measurement result. Memory data reading/removal function: The device can store a total of 32 groups of memorable values. All memory values can be removed after the battery is removed Low battery indicator Buzzer reminder function Users can set temperature alarm value Environment or object temperature measurement function The reference body site of the output temperature is Oral.
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    K Number
    K223044
    Device Name
    Digital Thermometer (Model QT001)
    Manufacturer
    Shen Zhen Rong Feng Technology Co., Ltd
    Date Cleared
    2023-05-10

    (223 days)

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

    Shen Zhen Rong Feng Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.
    Device Description
    The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode. The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes. The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures. QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.
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