EC-384OTL, VIDEO COLONSCOPE

EC-384OTL, VIDEO COLONSCOPE is an FDA 510(k)-cleared medical device (K961563) 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 June 18, 1996. Regulation: 8.