EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE is an FDA 510(k)-cleared medical device (K023401) 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 February 10, 2003. Regulation: 8.