MIROCAM CAPSULE ENDOSCOPE SYSTEM

MIROCAM CAPSULE ENDOSCOPE SYSTEM is an FDA 510(k)-cleared medical device (K111450) manufactured by Intromedic Co., 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 17, 2012. Regulation: 8.