Easycare Online
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K132371 FDA 510(k)
- FDA Product Code
- MNS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Easycare Online is a continuous, non-life-supporting ventilator device classified under the Anesthesiology medical specialty. It is a Class 2 medical device with product code MNS and regulation number 868.5895.
The device received FDA 510(k) clearance under K132371 through the Traditional pathway on November 22, 2013, following a determination of substantial equivalence. It is manufactured by Resmed, Ltd. and is intended for use in supporting the standard follow-up care of patients prescribed a compatible ResMed flow generator for obstructive sleep apnea or respiratory insufficiency.
Frequently asked questions
What is the Easycare Online device used for?
The Easycare Online device is intended for supporting the standard follow-up care of patients prescribed a compatible ResMed flow generator for obstructive sleep apnea or respiratory insufficiency, as stated in its FDA 510(k) clearance documentation.
How is the Easycare Online device classified and what regulatory pathway was used for its clearance?
The Easycare Online is a Class 2 medical device with product code MNS and regulation number 868.5895, and it received FDA 510(k) clearance under K132371 through the Traditional pathway on November 22, 2013, based on a determination of substantial equivalence.
Who manufactures the Easycare Online device and where is it located?
The Easycare Online device is manufactured by Resmed, Ltd., located at 9001 Spectrum Center Blvd., San Diego, CA 92123, United States, as indicated in the device’s authorization and establishment registration details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Welcome to EasyCare Online, EASYCARE ONLINE (K123557) — FDA 510(k) | Innolitics, K093684 - EASYCARE ONLINE | FDA 510 (k) | Resmed, Ltd., EASYCARE ONLINE (K093684) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132371 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K132371 24 fields · synced Sep 26, 2026