SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS is an FDA 510(k)-cleared medical device (K003529) manufactured by Edap Technomed, Inc.. 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 11, 2001. Regulation: 8.