Masimo Disposable Transflectance Forehead Sensor

Masimo Disposable Transflectance Forehead Sensor is an FDA 510(k)-cleared medical device (K160940) 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 November 22, 2016. Regulation: 8.