ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 is an FDA 510(k)-cleared medical device (K043574) manufactured by Renal Solutions, 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 June 2, 2005. Regulation: 8.