510(k) K083056

NEO-STAT CO2 <KG by Mercury Medical — Product Code CCK

K083056 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "NEO-STAT CO2 <KG". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Mercury Medical has at least 10 other 510(k) clearances on record.