DORNIER LITHOTRIPTER 140(DOLI 140)

DORNIER LITHOTRIPTER 140(DOLI 140) is an FDA 510(k)-cleared medical device (K011773) manufactured by Dornier. 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 June 21, 2001. Regulation: 8.