AUTOMATED ENDOSCOPE LEAK TESTER

AUTOMATED ENDOSCOPE LEAK TESTER is an FDA 510(k)-cleared medical device (K123704) manufactured by Olympus Medical Systems Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 2013. Regulation: 8.