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The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes. Its primary functions are; 1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions, Display a single subject's demographic data entered by the user. 2. Produce reports In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

The Vitalograph Model 6800 Pneumotrac is a diagnostic spirometer. The device was studied through validation bench testing against several international standards to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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