ELISIO-H HEMODIALYZER

ELISIO-H HEMODIALYZER is an FDA 510(k)-cleared medical device (K140191) manufactured by Nipro Medical Corporation. 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 April 13, 2014. Regulation: 8.