DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER

DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER is an FDA 510(k)-cleared medical device (K013471) manufactured by E.S.W.L. Products, 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 April 28, 2002. Regulation: 8.