CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack is an FDA 510(k)-cleared medical device (K183294) manufactured by STERIS Corporation. 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 January 2, 2019. Regulation: 8.