510(k) K083801

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 by Khn Solutions, LLC — Product Code DJZ

K083801 is an FDA 510(k) premarket notification submitted by Khn Solutions, LLC for the device "BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Khn Solutions, LLC has at least 3 other 510(k) clearances on record.