PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)

PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) is an FDA 510(k)-cleared medical device (K131028) manufactured by Pentax Medical Company. 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 April 9, 2014. Regulation: 8.