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The devices models DT Series (barring model DT-201A and DT-211A) are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

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This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for a range of digital thermometers. It does not contain specific information about acceptance criteria for device performance or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

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