Easycare Online
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K093684 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Easycare Online is a non-continuous ventilator designed to support the standard follow-up care of patients prescribed a compatible ResMed flow generator. It provides remote settings capabilities for the treatment of obstructive sleep apnea or respiratory insufficiency.
This device is authorized under FDA 510(k) clearance. It is manufactured by Resmed, Ltd. and is classified as a Class II medical device.
Frequently asked questions
What is the primary purpose of the Easycare Online device?
Easycare Online is a non-continuous ventilator designed to support the follow-up care of patients who have been prescribed a compatible ResMed flow generator. It allows for remote management of device settings to assist in the treatment of obstructive sleep apnea or respiratory insufficiency.
Is this device compatible with all ventilators?
No, the device is specifically designed to support the follow-up care of patients prescribed a compatible ResMed flow generator. It is not intended for use with non-compatible equipment.
What is the regulatory classification of this device?
Easycare Online is classified as a Class II medical device and is authorized under FDA 510(k) clearance.
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, K132371 FDA 510(k) - EASYCARE ONLINE | 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 | K093684 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K093684 24 fields · synced Sep 26, 2026