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K Number
K163256Device Name
Dual Mode Infrared Thermometer
Manufacturer
Date Cleared
2017-04-06
(136 days)
Product Code
Regulation Number
880.2910Why 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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