SMARTPILL GI MONITORING SYSTEM

SMARTPILL GI MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K053547) manufactured by The Smartpill 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 17, 2006. Regulation: 8.