AUDICOR CA300/CC100 Analyzer with SDB

AUDICOR CA300/CC100 Analyzer with SDB is an FDA 510(k)-cleared medical device (K151433) manufactured by Inovise Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2016. Regulation: 8.