ResMed S8 Prime CPAP System
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K033841 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)
The ResMed S8 Prime CPAP System is a device for the treatment of obstructive sleep apnea (OSA) in adult patients. It operates as a continuous positive airway pressure (CPAP) system to provide respiratory support during sleep.
The device is supplied by ResMed, Ltd. and is authorized under FDA 510K clearance. It is classified as a Class II medical device and is regulated under product code BZD. The system is designed for use in the treatment of sleep apnea and is not indicated for other conditions.
Frequently asked questions
What is the ResMed S8 Prime CPAP System used for?
The ResMed S8 Prime CPAP System is designed for the treatment of obstructive sleep apnea (OSA) in adult patients. It operates as a continuous positive airway pressure (CPAP) system to provide respiratory support during sleep.
How is the ResMed S8 Prime CPAP System supplied?
The device is supplied by ResMed, Ltd. and is authorized under FDA 510K clearance. It is classified as a Class II medical device and is regulated under product code BZD.
Is the ResMed S8 Prime CPAP System reusable or single-use?
The device is designed for reuse in the treatment of sleep apnea. It is not indicated for single-use or for treating conditions other than obstructive sleep apnea in adult patients.
What are the storage requirements for the ResMed S8 Prime CPAP System?
The device should be stored in a clean, dry environment at room temperature when not in use. Proper maintenance and cleaning according to the manufacturer's instructions are essential to ensure optimal performance and longevity of the system.
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: Resmed | The World Leader in Sleep Health, CPAP-Geräte, Masken, Zubehör und Ersatzteile | Resmed Shop, Amazon.com: Resmed S8 Cpap Machine, PDF S8 Series II - ResMed, Amazon.com: Cpap Resmed S8
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033841 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K033841 24 fields · synced Oct 1, 2026