TG 2, TRI-GARD PRESSURE MONITOR

TG 2, TRI-GARD PRESSURE MONITOR is an FDA 510(k)-cleared medical device (K790841) manufactured by Sorensen Research. 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 26, 1979. Regulation: 8.