Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is an FDA 510(k)-cleared medical device (K232389) 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 September 6, 2023. Regulation: 8.