510(k) K062971

BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS by Akers Biosciences, Inc. — Product Code DJZ

K062971 is an FDA 510(k) premarket notification submitted by Akers Biosciences, Inc. for the device "BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 18, 2006. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Akers Biosciences, Inc. has at least 4 other 510(k) clearances on record.