Capnostream™35 Portable Respiratory Monitor (PM35MN)

Capnostream™35 Portable Respiratory Monitor (PM35MN) is an FDA 510(k)-cleared medical device (K253030) manufactured by Covidien, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2026. Regulation: 8.