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Masimo Corp.
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MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR is an FDA 510(k)-cleared medical device (K032551) manufactured by Masimo Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2004. Regulation: 8.