Andersen EOGas 4 SteriTest

Andersen EOGas 4 SteriTest is an FDA 510(k)-cleared medical device (K151585) manufactured by Andersen Sterilizers, Inc.. 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 November 17, 2015. Regulation: 8.