MASIMO RADICAL Y PULSE CO-OXIMETER

MASIMO RADICAL Y PULSE CO-OXIMETER is an FDA 510(k)-cleared medical device (K110028) 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 16, 2011. Regulation: 8.