STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is an FDA 510(k)-cleared medical device (K192025) manufactured by Advanced Sterilization Products (Asp). 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 22, 2020. Regulation: 8.