FLOSENSE, MODEL 29-8010

FLOSENSE, MODEL 29-8010 is an FDA 510(k)-cleared medical device (K990962) manufactured by Sdi Diagnostics, 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 January 6, 2000. Regulation: 8.