E-Z-EM ENDOSCOPIC CO2 REGULATOR

E-Z-EM ENDOSCOPIC CO2 REGULATOR is an FDA 510(k)-cleared medical device (K053008) manufactured by E-Z-Em, 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 December 26, 2005. Regulation: 8.