EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER is an FDA 510(k)-cleared medical device (K132672) manufactured by Dornier Medtech America. 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 September 22, 2013. Regulation: 8.