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510(k) Data Aggregation

    K Number
    K163256
    Device Name
    Dual Mode Infrared Thermometer
    Manufacturer
    Date Cleared
    2017-04-06

    (136 days)

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

    Intelliworks LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages.
    Device Description
    The Dual Mode Infrared Thermometer (Model DM-IR200) is a hand-held, non-sterile, reusable, battery powered device designed to measure human body temperature via one of two body sites: the ear canal or skin of the forehead. The DM-IR200 thermometer utilizes infrared technology to measure the natural thermal infrared energy emitted from the surface of the forehead or from the eardrum tissue.
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