ELISIO-H AND ELISIO-M HEMODIALYZERS

ELISIO-H AND ELISIO-M HEMODIALYZERS is an FDA 510(k)-cleared medical device (K122347) 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 30, 2013. Regulation: 8.