510(k) K053174

LOFLO C5 CO2 SENSOR by Respironics Novametrix, LLC — Product Code CCK

K053174 is an FDA 510(k) premarket notification submitted by Respironics Novametrix, LLC for the device "LOFLO C5 CO2 SENSOR". The FDA issued a decision of Substantially Equivalent on January 12, 2006. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Respironics Novametrix, LLC has at least 10 other 510(k) clearances on record.