510(k) K062115

CARBON DIOXIDE MONITOR, MODEL OLG-2800A by Nihon Kohden America, Inc. — Product Code CCK

K062115 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "CARBON DIOXIDE MONITOR, MODEL OLG-2800A". The FDA issued a decision of Substantially Equivalent on December 27, 2006. 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.