Masimo SedLine Sedation Monitor and Accessories

Masimo SedLine Sedation Monitor and Accessories is an FDA 510(k)-cleared medical device (K203113) manufactured by Masimo Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2022. Regulation: 8.