510(k) K051092

DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC by GE Healthcare — Product Code CCL

K051092 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC". The FDA issued a decision of Substantially Equivalent on May 25, 2005. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. GE Healthcare has at least 10 other 510(k) clearances on record.