CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP is an FDA 510(k)-cleared medical device (K970595) manufactured by Circon Video. 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, 1997. Regulation: 8.