510(k) K210019

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ by Unimed Medical Supplies, Inc. — Product Code CCK

K210019 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+". The FDA issued a decision of Substantially Equivalent on March 4, 2021. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Unimed Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.