510(k) K261360

EasyCare Tx 2 by Resmed Corp — Product Code MOD

K261360 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 August 27, 2026. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Resmed Corp has at least 10 other 510(k) clearances on record.