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The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.

The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.

This document is a 510(k) premarket notification decision letter from the FDA for the SpiroSoft device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

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