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Datex-Ohmeda
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DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE is an FDA 510(k)-cleared medical device (K011670) manufactured by Datex-Ohmeda. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2001. Regulation: 8.