510(k) K203762

Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector by Covidien — Product Code CCK

K203762 is an FDA 510(k) premarket notification submitted by Covidien for the device "Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector". The FDA issued a decision of Substantially Equivalent on September 17, 2021. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Covidien has at least 10 other 510(k) clearances on record.