KSEA N2O ENDOFLATOR

KSEA N2O ENDOFLATOR is an FDA 510(k)-cleared medical device (K980134) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1998. Regulation: 8.