510(k) K123038

SWISS LITHOBREAKER by E.M.S Electro Medical Systems S.A — Product Code FFK

K123038 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "SWISS LITHOBREAKER". The FDA issued a decision of Substantially Equivalent on January 16, 2013. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), 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.