GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM is an FDA 510(k)-cleared medical device (K120532) manufactured by Getinge Sourcing, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2013. Regulation: 8.