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Nellcor Puritan Bennett, Inc.
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DURAMAX REUSABLE OXIMETRY SENSOR is an FDA 510(k)-cleared medical device (K070408) manufactured by Nellcor Puritan Bennett, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 24, 2007. Regulation: 8.