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The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.

Infrared Ear Thermometer Model ET-100 Series

This document is a 510(k) clearance letter from the FDA for an Infrared Ear Thermometer, Model ET-100 Series. It does not contain the detailed study results, acceptance criteria, or other specific information about device performance and validation that you have requested.

Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed, but does not detail the technical performance data from studies.

To answer your questions, I would need access to the actual 510(k) submission packet, which would contain the performance testing reports.

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