510(k) K140683

0180 INTUITION, 0072 PRECISION by Arcoma AB — Product Code KPR

K140683 is an FDA 510(k) premarket notification submitted by Arcoma AB for the device "0180 INTUITION, 0072 PRECISION". The FDA issued a decision of Substantially Equivalent on June 3, 2014. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Arcoma AB has at least 1 other 510(k) clearance on record.