SENTEC DIGITAL MONITOR MODEL #SDM

SENTEC DIGITAL MONITOR MODEL #SDM is an FDA 510(k)-cleared medical device (K041548) manufactured by Sentec, 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 August 8, 2004. Regulation: 8.