PENTAX Medical Video Bronchoscope EB-J10 Series

PENTAX Medical Video Bronchoscope EB-J10 Series is an FDA 510(k)-cleared medical device (K200678) 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 July 29, 2020. Regulation: 8.