
Nellcor Puritan Bennett, Inc.
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OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) is an FDA 510(k)-cleared medical device (K012891) 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 March 6, 2002. Regulation: 8.