
Covidien
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COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 is an FDA 510(k)-cleared medical device (K111933) manufactured by Covidien. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2012. Regulation: 8.