510(k) K161768

LUCAS 3 Chest Compression System by Jolife AB — Product Code DRM

K161768 is an FDA 510(k) premarket notification submitted by Jolife AB for the device "LUCAS 3 Chest Compression System". The FDA issued a decision of Substantially Equivalent on November 9, 2016. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Jolife AB has at least 4 other 510(k) clearances on record.