
Covidien, Formerly Nellcor Puritan Bennett, Inc.
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NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN is an FDA 510(k)-cleared medical device (K123581) manufactured by Covidien, Formerly 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 8, 2013. Regulation: 8.