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510(k) Data Aggregation

    K Number
    K160816
    Device Name
    Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
    Date Cleared
    2016-09-21

    (181 days)

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

    NEXMED TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
    Device Description
    The subject device uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The subject device intends to detect the temperature of patients of all ages. The subject device includes 2 series: ThermoFlash and MyThermo. The ThermoFlash thermometers contain 5 models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, while MyThermo thermometer contains one model BW-CX10. They all have the following basic functions: - Sound alarm if temperature is exceeded. - - LCD back-lighted digital screen. - - Data displayed in Celsius or Fahrenheit. - - Automatic stop (energy saver). - - Small, convenient, easy to use. - Their differences are in appearance and functions. The LX-26E and LX-360 are same in functions, while LX-260TE and LX-361T contain additional language function, BW-CX10 and PRO LX-261E contain additional rechargeable function, and BW-CX10 contains additional Bluetooth function.
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