BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 is an FDA 510(k)-cleared medical device (K083801) manufactured by Khn Solutions, LLC. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 18, 2009. Regulation: 8.