LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT

LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT is an FDA 510(k)-cleared medical device (K081043) 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 July 6, 2008. Regulation: 8.