Identifiers
- 510(k) Number
- K150639 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 AF541 EE Full Face Mask is a ventilator, non-continuous (respirator) designed for noninvasive ventilation (NIV) in anesthesia and respiratory care. It provides a sealed interface over the nose and mouth to deliver controlled airflow, supporting respiratory function during procedures or patient care.
This device is intended for single-use and is supplied sterile. It features interchangeable under-the-nose (UTN) and over-the-nose (OTN) cushions for improved patient comfort and mask rotation. The AF541 EE has received FDA 510K clearance under the classification of Class II medical devices, adhering to regulatory standards for ventilatory support in clinical settings.
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: Respironics AF541 - Hospital Noninvasive Ventilation NIV Mask - Philips, Philips AF541 Face Masks | Medline, Respironics AF541 - Hospital Noninvasive Ventilation NIV Mask - philips.ee, Philips AF541 Oro-Nasal Mask with CAPSTRAP Headgear and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150639 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K150639 24 fields · synced Sep 19, 2026