SERIES 400 GASTROENTEROLOGY SYSTEM

SERIES 400 GASTROENTEROLOGY SYSTEM is an FDA 510(k)-cleared medical device (K944620) manufactured by Marks & Murase. 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 April 26, 1995. Regulation: 8.