510(k) K843970

MODEL IM1074 END-TIDAL CO2 MODULE by Gould, Inc. — Product Code CCK

K843970 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "MODEL IM1074 END-TIDAL CO2 MODULE". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Gould, Inc. has at least 10 other 510(k) clearances on record.