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Nitric oxide tests get special controls

This article was originally published in The Gray Sheet

Executive Summary

Devices are officially downclassified from Class III to Class II in July 7 final rule. A breath nitric oxide test system Class II special controls guidance accompanies the rule. The downclassification was prompted by a petition from Aerocrine AB. The device, which aids in monitoring asthma therapy, received 510(k) clearance earlier this year, following an April 30 classification order (1"The Gray Sheet" May 5, 2003, p. 26)...
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