TSO3 OZONE CHEMICAL INDICATOR

TSO3 OZONE CHEMICAL INDICATOR is an FDA 510(k)-cleared medical device (K021161) manufactured by Technologies of Sterilization With Oxone, Tso3, 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 August 26, 2003. Regulation: 8.