ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO is an FDA 510(k)-cleared medical device (K103264) manufactured by Olympus Medical Systems Corporation. 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 22, 2011. Regulation: 8.