
Electro Medical Systems SA
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EMS SWISS LITHOCLAST LITHOTRIPTER is an FDA 510(k)-cleared medical device (K963285) manufactured by Electro Medical Systems SA. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1997. Regulation: 8.