MASIMO SET RAD-8 PULSE OXIMETER

MASIMO SET RAD-8 PULSE OXIMETER is an FDA 510(k)-cleared medical device (K053269) manufactured by Masimo Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2005. Regulation: 8.