510(k) K181624

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line by Oridion Medical 1987 , Ltd. — Product Code CCK

K181624 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line". The FDA issued a decision of Substantially Equivalent on March 22, 2019. 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.