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510(k) Data Aggregation

    K Number
    K201600
    Device Name
    Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
    Date Cleared
    2021-12-10

    (546 days)

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

    Kangfu Medical Equipment Factory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared thermometer, models KFT-22M, KFT-22, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 is designed to measuring human body temperature through ear or forehead in the healthcare environments or home use and is non-sterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns.
    Device Description
    The KFT series infrared thermometer measures the body temperature through receiving the infrared energy radiation from the surface of human body. It is capacified with forehead mode and ear temperature mode, directly shown on the LCD screen. - The device is widely used for home healthcare and medical environment. - . The product is mainly comprised of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. - . It focuses the infrared from the human's forehead or ear by the Fresnel lens.
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    K Number
    K182652
    Device Name
    COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
    Date Cleared
    2018-11-20

    (57 days)

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

    Kangfu Medical Equipment Factory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.
    Device Description
    COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/ KFT-05/KFT-06/ KFT-07/KFT-08/ KFT-09/KFT-10) is a hand-held electronic thermometer, it comprised of an electronic thermo resistor (thermistor) sensor connected to printed circuit board(PCB) with liquid crystal display(LCD) user readout. The outer material of thermometer is made of ABS and the measuring tip is stainless steel. The thermometer using a temperature sensor to output an electrical signal, and then converting the current signal into a liquid crystal digital display temperature. The thermometers are powered by LR41 battery. The battery can be replaced.
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