
Gambro Renal Care Products
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PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) is an FDA 510(k)-cleared medical device (K993064) manufactured by Gambro Renal Care 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 5, 1999. Regulation: 8.