510(k) K251641

GF-310R Multigas Unit (GF-310R) by Nihon Kohden Corporation — Product Code CCK

K251641 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "GF-310R Multigas Unit (GF-310R)". The FDA issued a decision of Substantially Equivalent on August 12, 2026. 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.