510(k) K063813

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA by Ventlab Corp. — Product Code CCK

K063813 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA". The FDA issued a decision of Substantially Equivalent on March 26, 2008. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Ventlab Corp. has at least 10 other 510(k) clearances on record.