PRISMA M60/M100 SETS

PRISMA M60/M100 SETS is an FDA 510(k)-cleared medical device (K032431) manufactured by Gambro, 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 September 14, 2003. Regulation: 8.