THE RELIANCE PI PROCESS INDICATOR, MODEL D5116

THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 is an FDA 510(k)-cleared medical device (K043482) 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 December 20, 2004. Regulation: 8.