PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) is an FDA 510(k)-cleared medical device (K946279) manufactured by Cobe Renal Care, 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 9, 1997. Regulation: 8.