510(k) K031411

MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 by Mercury Medical — Product Code CCK

K031411 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MINI STATCO2 CO2 DETECTOR, MODEL 10-55371". The FDA issued a decision of Substantially Equivalent on July 30, 2003. 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.