ECONOLITH E3000, MODEL 3000 (SW-6)

ECONOLITH E3000, MODEL 3000 (SW-6) is an FDA 510(k)-cleared medical device (K040461) manufactured by Medispec, Ltd.. 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 May 24, 2004. Regulation: 8.