ECONOLITH EM1000

ECONOLITH EM1000 is an FDA 510(k)-cleared medical device (K063504) 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 March 8, 2007. Regulation: 8.