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This document provides a summary of the 510(k) premarket notification for the IR Ear/Forehead thermometer, detailing its intended use, technological characteristics, and substantial equivalence to

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The 39510k summary - govfdaaccessdatawww is a summary report that provides information on medical devices subject to FDA regulations.

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The purpose of the 39510k summary - govfdaaccessdatawww is to ensure that medical devices meet FDA regulations and are safe and effective for use.

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The 39510k summary - govfdaaccessdatawww requires reporting of information such as device description, intended use, technological characteristics, and any clinical data or studies.