510(k) clearance

EasyCare Tx 2

FDA 510(k) source

510(k) number

K261360

Applicant

Resmed Corp

Decision date

Aug 27, 2026

Date received

Apr 24, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MOD

Device type

Accessory To Continuous Ventilator (Respirator)

Device class

Class II

Regulation

21 CFR 868.5895

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

San Diego, CA, US