MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES

MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K091057) 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 July 8, 2009. Regulation: 8.