510(k) K132478

AIR-FLOW HANDY 3.0 by E.M.S Electro Medical Systems S.A — Product Code EFB

K132478 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "AIR-FLOW HANDY 3.0". The FDA issued a decision of Substantially Equivalent on April 11, 2014. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.