PENTAX EPK-I5020 VIDEO PROCESSOR

PENTAX EPK-I5020 VIDEO PROCESSOR is an FDA 510(k)-cleared medical device (K113873) manufactured by Pentax of America, Inc.. 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 21, 2012. Regulation: 8.