STERITEC INTEGRAPH MODEL CI-101

STERITEC INTEGRAPH MODEL CI-101 is an FDA 510(k)-cleared medical device (K960441) manufactured by Steritec Products Mfg Co, 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 May 7, 1997. Regulation: 8.