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The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system, targeted at a population age range of between 5 and 85 and capable of measuring directly the following parameters:
a. Tidal volume
b. Breathing frequency
c. Expired oxygen
d. Expired carbon dioxide

Based on the measured parameters the instrument calculates the following parameters:
a. Oxygen uptake
b. Carbon dioxide production
c. Ventilation
d. Respiratory exchange ratio
e. Time of inspiration
f. Time of expiration
g. End tidal oxygen
h. End tidal carbon dioxide
i. Anaerobic threshold

The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system.

This document is a 510(k) premarket notification letter from the FDA regarding the "Pulmolab EX671 Exercise Testing System." It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain any information about acceptance criteria, a study that proves the device meets those criteria, or any details about device performance or testing methodologies.

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. The document is an approval letter, not a study report or a summary of performance data.

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