DIXTAL DZ-4100 SERIES PULSE OXIMETER

DIXTAL DZ-4100 SERIES PULSE OXIMETER is an FDA 510(k)-cleared medical device (K103285) manufactured by Dixtal Medical, 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 July 24, 2011. Regulation: 8.