510(k) K181997

Swiss LithoClast Trilogy by E.M.S Electro Medical Systems S.A — Product Code FEO

K181997 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "Swiss LithoClast Trilogy". The FDA issued a decision of Substantially Equivalent on August 30, 2018. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.