GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER

GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER is an FDA 510(k)-cleared medical device (K070657) 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 April 4, 2007. Regulation: 8.