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510(k) Data Aggregation

    K Number
    K201579
    Device Name
    Infrared Thermometer
    Date Cleared
    2021-01-15

    (218 days)

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

    Shenzhen Xunwei Industrial Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared thermometer, Model XW-60 is intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.
    Device Description
    The device is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of all ages in the home. It has the following features: - . Three button operation; - Optional mode for Fahrenheit and Celsius; . - Short measurement response time; - . There are 20 measurement data can be memorized and stored; - . Two color backlight display; - Low and high temperature warning beeps; - Automatic shutdown feature to save energy; ● - . Low battery indication;
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