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    K Number
    K202741
    Device Name
    Infrared Forehead Thermometer
    Manufacturer
    Shenzhen Combei Technology Co., Ltd.
    Date Cleared
    2021-07-07

    (292 days)

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

    Shenzhen Combei Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
    Device Description
    The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.
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