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    K Number
    K112189
    Device Name
    THERMO PAL INFRARED EAR THERMOMETER
    Manufacturer
    DIGIO2 INTERNATIONAL CO., LTD.
    Date Cleared
    2012-01-13

    (168 days)

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

    DIGIO2 INTERNATIONAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.
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