510(k) K013845

MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE by Oridion Medical 1987 , Ltd. — Product Code CCK

K013845 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Oridion Medical 1987 , Ltd. has at least 10 other 510(k) clearances on record.