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510(k) Data Aggregation

    K Number
    K210014
    Device Name
    Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
    Date Cleared
    2021-06-04

    (151 days)

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

    Guandong Genial Technology CO., LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.
    Device Description
    The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) 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 Forehead Thermometer (Model: T80、T81、T84、T85),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 and Backlight f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger) g) 2×1.5V AA dry batteries The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.
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