NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500

NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 is an FDA 510(k)-cleared medical device (K071263) 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 August 23, 2007. Regulation: 8.