MODULARIS VARIOSTAR

MODULARIS VARIOSTAR is an FDA 510(k)-cleared medical device (K070799) manufactured by Siemens Medical Solutions USA, Inc.. 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 October 31, 2007. Regulation: 8.