OLPUR DIALYZER, MODEL HD 190

OLPUR DIALYZER, MODEL HD 190 is an FDA 510(k)-cleared medical device (K050603) manufactured by Nephros, 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 8, 2005. Regulation: 8.