PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET is an FDA 510(k)-cleared medical device (K011221) manufactured by Gambro Renal Products. 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 30, 2001. Regulation: 8.