GEMINI LITHOTRIPTER

GEMINI LITHOTRIPTER is an FDA 510(k)-cleared medical device (K121656) manufactured by Dornier Medtech America, 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 September 23, 2012. Regulation: 8.