ELRAN 01 SYSTEM

ELRAN 01 SYSTEM is an FDA 510(k)-cleared medical device (K002431) manufactured by Envision Advanced Medical System, 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 October 23, 2000. Regulation: 8.