EC-3800TL, VIDEO COLONOSCOPE

EC-3800TL, VIDEO COLONOSCOPE is an FDA 510(k)-cleared medical device (K951579) 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 March 20, 1996. Regulation: 8.