BREATHKEY MODEL G10/BREATHKEY MODEL G30X

BREATHKEY MODEL G10/BREATHKEY MODEL G30X is an FDA 510(k)-cleared medical device (K052804) manufactured by Omega Point Systems, LLC. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 8, 2005. Regulation: 8.