POLARIS 2004 CAPNOGRAPH

POLARIS 2004 CAPNOGRAPH is an FDA 510(k)-cleared medical device (K040011) manufactured by Oridion , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2004. Regulation: 8.