510(k) K183394

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO by GE Healthcare Finland Oy — Product Code CCK

K183394 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO". The FDA issued a decision of Substantially Equivalent on May 1, 2019. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.