PRISMA M10 PRE SET

PRISMA M10 PRE SET is an FDA 510(k)-cleared medical device (K063183) manufactured by Gambro Renal Products, 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 February 14, 2007. Regulation: 8.