PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is an FDA 510(k)-cleared medical device (K183516) 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 September 5, 2019. Regulation: 8.