EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM is an FDA 510(k)-cleared medical device (K040883) manufactured by Advanced Sterilization Products. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2005. Regulation: 8.