510(k) K011536

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE by Oridion Medical 1987 , Ltd. — Product Code CCK

K011536 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE". The FDA issued a decision of Substantially Equivalent on November 14, 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.