EasyCare Tx 2— 510(k) K261360
Substantially EquivalentResmed Corp
FDA 510(k) clearance K261360 for EasyCare Tx 2, Substantially Equivalent on 2026-08-27. Applicant: Resmed Corp. Device class: 2.
Summary
ResMed's EasyCare Tx 2 is filed under product code MOD, accessories to continuous ventilators (respirators). The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 868.5895. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from San Diego, California. Review took 125 calendar days (April 24 to August 27, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Resmed Corp
- Product code
- Product code MOD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MOD
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