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The Basal Digital Thermometer is intended to measure the human body temperature for children and adults, especial for woman. It has precise digital display and be used in household environment and doctor in clinics as reference.

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This document is a 510(k) clearance letter for a "Basic Digital Thermometer, Model KD-2160." It formally states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data for the device itself. It is a regulatory approval letter, not a study report. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

To answer your request, I would need a document detailing the performance study, such as a summary of safety and effectiveness, or a clinical study report submitted to the FDA during the 510(k) process.

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