EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE

EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE is an FDA 510(k)-cleared medical device (K021278) manufactured by Pentax Precision Instrument Corp.. 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 5, 2002. Regulation: 8.