SYSTEM 1E Liquid Chemical Sterilant Processing System

SYSTEM 1E Liquid Chemical Sterilant Processing System is an FDA 510(k)-cleared medical device (K180342) manufactured by Steris Corporations. 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 3, 2018. Regulation: 8.