MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS

MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS is an FDA 510(k)-cleared medical device (K053477) 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 March 15, 2006. Regulation: 8.