OMEGA ANGIOSCOPES (OMEGASCOPES)

OMEGA ANGIOSCOPES (OMEGASCOPES) is an FDA 510(k)-cleared medical device (K911090) manufactured by Omega Universal Technologies, Ltd.. 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 July 30, 1991. Regulation: 8.