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Masimo Corporation
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LNOPV AD-L AND PD-L OXIMETRY SENSORS is an FDA 510(k)-cleared medical device (K050068) 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 February 8, 2005. Regulation: 8.