510(k) K161860

TG-970P CO2 Sensor Kit by Nihon Kohden Corporation — Product Code CCK

K161860 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "TG-970P CO2 Sensor Kit". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.