CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD

CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD is an FDA 510(k)-cleared medical device (K101995) manufactured by Oridion Capnography, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2011. Regulation: 8.