510(k) K192713

Altera Filter and HME/Filter by Meditera Tibbi Malzeme San VE Tic AS — Product Code CAH

K192713 is an FDA 510(k) premarket notification submitted by Meditera Tibbi Malzeme San VE Tic AS for the device "Altera Filter and HME/Filter". The FDA issued a decision of Substantially Equivalent on March 16, 2020. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Meditera Tibbi Malzeme San VE Tic AS has at least 2 other 510(k) clearances on record.