MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES

MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K111403) 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 December 29, 2011. Regulation: 8.