PENTAX Medical EPK-3000 Video Imaging System

PENTAX Medical EPK-3000 Video Imaging System is an FDA 510(k)-cleared medical device (K182846) manufactured by Pentax of America, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 2019. Regulation: 8.