BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE is an FDA 510(k)-cleared medical device (K120126) manufactured by Barosense, 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 September 9, 2012. Regulation: 8.