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510(k) Data Aggregation

    K Number
    K202481
    Device Name
    ThermArt (Model IR-EFT)
    Date Cleared
    2021-09-28

    (396 days)

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

    Comper Chuangxiang (Beijing) technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a non-sterile reusable, contact thermometer, intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment.
    Device Description
    The ThermArt (Model IR-EFT) is a hand-held, battery powered device designed to measure human body temperature. This Thermometer takes the body temperature the infrared energy emitted from the forehead skin or the ear canal. The Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the accurate reading of the body temperature with just a gentle touch.
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    K Number
    K191668
    Device Name
    Infrared Forehead Thermometer (Model IR-FT)
    Date Cleared
    2019-10-18

    (119 days)

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

    Comper Chuangxiang (Beijing) Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.
    Device Description
    The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.
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