Search Results

The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.

Not Found

This document appears to be an FDA 510(k) clearance letter for a "Phoenix Digital Thermometer." As such, it grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed acceptance criteria for device performance or the study details proving it meets those criteria, as typically found in a clinical study report or a more extensive submission summary.

The letter confirms the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not describe a specific study proving the device meets particular acceptance criteria in the way you've outlined.

Therefore, I cannot provide the requested information in the structured format you've asked for based solely on the provided text. The document acts as an approval notice, not the validation study itself.

To answer your questions, I would need access to the actual 510(k) submission summary or supporting documentation that was reviewed by the FDA, which would detail the performance data, acceptance criteria, and study design used to demonstrate substantial equivalence.

Ask a specific question about this device