Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask,…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203347 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)
This device is a Sleep Apnea Breathing Therapy Mask, designed to deliver continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea. The masks provide a sealed interface over the nose and/or mouth to ensure proper airflow delivery, reducing airway obstruction during sleep. Available in full-face, nasal, and nasal pillow designs, they accommodate varying patient preferences and anatomical needs.
The masks are intended for single-use or reusable applications, depending on the model, and are supplied sterile or non-sterile as specified. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance and MDR authorization. Each model (YF-01, YF-02, YF-03, YN-02, YN-03, YP-01) is designed for compatibility with standard CPAP machines and must be stored according to manufacturer instructions to maintain integrity. No MRI safety information is provided.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203347 | Class II | Active |
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Manufacturer
- Manufacturer
- Suzhou Yuyue Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K203347 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026