Masimo MightySat Rx Fingertip Pulse Oximeter

Masimo MightySat Rx Fingertip Pulse Oximeter is an FDA 510(k)-cleared medical device (K181956) 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 January 22, 2019. Regulation: 8.