ENDOSCOPE REPROCESSOR OER-MINI

ENDOSCOPE REPROCESSOR OER-MINI is an FDA 510(k)-cleared medical device (K120357) 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 December 19, 2012. Regulation: 8.