REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360

REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 is an FDA 510(k)-cleared medical device (K071764) manufactured by Obtech Medical Sarl. 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 October 23, 2007. Regulation: 8.