Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+

About This 510(k) Submission

K210019 is an FDA 510(k) clearance for the Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on March 4, 2021, 59 days after receiving the submission on January 4, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.