MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS

MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS is an FDA 510(k)-cleared medical device (K071024) 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 June 28, 2007. Regulation: 8.