Nellcor Bedside SpO2 Patient Monitoring System

Nellcor Bedside SpO2 Patient Monitoring System is an FDA 510(k)-cleared medical device (K142865) 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 March 25, 2015. Regulation: 8.