510(k) K963285

EMS SWISS LITHOCLAST LITHOTRIPTER by Electro Medical Systems SA — Product Code FFK

K963285 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "EMS SWISS LITHOCLAST LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on February 13, 1997. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.