BALLOON FOR ULTRASONIC ENDOSCOPES

BALLOON FOR ULTRASONIC ENDOSCOPES is an FDA 510(k)-cleared medical device (K992178) manufactured by N.M. Beale Co., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2000. Regulation: 8.