510(k) K151421

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines by Salter Labs — Product Code CCK

K151421 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines". The FDA issued a decision of Substantially Equivalent on March 10, 2016. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Salter Labs has at least 10 other 510(k) clearances on record.