PENTAX EPK-I5010 VIDEO PROCESSOR

PENTAX EPK-I5010 VIDEO PROCESSOR is an FDA 510(k)-cleared medical device (K122470) manufactured by Pentax Medical. 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 April 9, 2013. Regulation: 8.