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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

This document is a 510(k) premarket notification response from the FDA for a Digital Clinical Thermometer (Models ST-833A & ST-834A). It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and therefore permits its marketing. However, it does not include the details of any performance study, test results, or specific acceptance criteria (like accuracy, precision, etc.) that would typically be associated with such a study.

Therefore, I cannot extract the requested information from the provided text.

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