Masimo Rad-97 Pulse CO-Oximeter and Accessories

Masimo Rad-97 Pulse CO-Oximeter and Accessories is an FDA 510(k)-cleared medical device (K193626) 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 August 9, 2020. Regulation: 8.