MASIMO SET RADICAL 7 PULSE CO-OXIMETER

MASIMO SET RADICAL 7 PULSE CO-OXIMETER is an FDA 510(k)-cleared medical device (K061204) 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 July 26, 2006. Regulation: 8.