510(k) K241939

EasyCare Tx 2 by Resmed Corp — Product Code BZD

K241939 is an FDA 510(k) premarket notification submitted by Resmed Corp for the device "EasyCare Tx 2". The FDA issued a decision of Substantially Equivalent on September 27, 2024. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Resmed Corp has at least 10 other 510(k) clearances on record.