STERITEC EMU-GRAPH, MODEL NO. CI 131/US

STERITEC EMU-GRAPH, MODEL NO. CI 131/US is an FDA 510(k)-cleared medical device (K040901) manufactured by Steritec Products, 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 September 8, 2004. Regulation: 8.