BIPRO MODEL SDS-CB200

BIPRO MODEL SDS-CB200 is an FDA 510(k)-cleared medical device (K033118) manufactured by Medical Solutions International. 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 June 27, 2004. Regulation: 8.