ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE is an FDA 510(k)-cleared medical device (K030960) manufactured by Acmi Corporation. 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 July 15, 2003. Regulation: 8.