ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 is an FDA 510(k)-cleared medical device (K042225) 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 September 9, 2004. Regulation: 8.