ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 is an FDA 510(k)-cleared medical device (K070739) 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 May 24, 2007. Regulation: 8.