ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK

ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK is an FDA 510(k)-cleared medical device (K081518) 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 September 4, 2008. Regulation: 8.