510(k) K083456

NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P by Nihon Kohden America, Inc. — Product Code CCK

K083456 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P". The FDA issued a decision of Substantially Equivalent on March 2, 2009. 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 America, Inc. has at least 10 other 510(k) clearances on record.