510(k) K890112

ENGSTROM ELIZA + CO2 ANALYZER by Gambro, Inc. — Product Code CCK

K890112 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "ENGSTROM ELIZA + CO2 ANALYZER". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Gambro, Inc. has at least 10 other 510(k) clearances on record.