GETINGE 400HC-E / SERIES STEAM STERILIZER

GETINGE 400HC-E / SERIES STEAM STERILIZER is an FDA 510(k)-cleared medical device (K122071) 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 March 11, 2013. Regulation: 8.