TSO3 OZONE STERILIZER, MODEL 125L

TSO3 OZONE STERILIZER, MODEL 125L is an FDA 510(k)-cleared medical device (K020875) 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 25, 2003. Regulation: 8.