510(k) K952325

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) by Icor AB — Product Code CCK

K952325 is an FDA 510(k) premarket notification submitted by Icor AB for the device "ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Icor AB has at least 10 other 510(k) clearances on record.