
Masimo Corporation
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MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 is an FDA 510(k)-cleared medical device (K092838) 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 October 14, 2009. Regulation: 8.