510(k) K123195

CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES by GE Healthcare Finland Oy — Product Code CCL

K123195 is an FDA 510(k) premarket notification submitted by GE Healthcare Finland Oy for the device "CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 28, 2013. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. GE Healthcare Finland Oy has at least 10 other 510(k) clearances on record.