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Masimo Corporation
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MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS is an FDA 510(k)-cleared medical device (K120657) 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 18, 2012. Regulation: 8.