Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is an FDA 510(k)-cleared medical device (K212161) 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 5, 2023. Regulation: 8.