510(k) K021576

MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 by Mercury Medical — Product Code CCK

K021576 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370". The FDA issued a decision of Substantially Equivalent on November 4, 2002. 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.