510(k) K093525

ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE by Ventlab Corp. — Product Code CCK

K093525 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE". The FDA issued a decision of Substantially Equivalent on December 10, 2009. 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.