510(k) K192563

Altera gas Sampling Lines by Meditera Tibbi Malzeme San VE Tic AS — Product Code CCK

K192563 is an FDA 510(k) premarket notification submitted by Meditera Tibbi Malzeme San VE Tic AS for the device "Altera gas Sampling Lines". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Meditera Tibbi Malzeme San VE Tic AS has at least 2 other 510(k) clearances on record.