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    K Number
    K081162
    Device Name
    TEMPTOUCH DERMAL THERMOMETER
    Manufacturer
    DIABETICA SOLUTIONS, INC.
    Date Cleared
    2008-05-08

    (14 days)

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

    DIABETICA SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TempTouch® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature of people of all ages.
    Device Description
    The TempTouch® is a handheld, 9V battery-operated device that measures the surface temperature of the skin. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin.
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