NXSTAGE SYSTEM ONE

NXSTAGE SYSTEM ONE is an FDA 510(k)-cleared medical device (K050525) manufactured by Nxstage Medical, 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 23, 2005. Regulation: 8.