
Covidien, LLC
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NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K120773) manufactured by Covidien, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2012. Regulation: 8.