RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L is an FDA 510(k)-cleared medical device (K081659) 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 8, 2008. Regulation: 8.