Identifiers
- 510(k) Number
- K061874 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 Twilight II Nasal Mask is a non-continuous ventilator accessory designed for use with positive airway pressure devices, such as CPAP. It is indicated for the treatment of adult obstructive sleep apnea in patients weighing over 30 kg and features a port on the mask swivel to facilitate pressure measurement.
This device is authorized under FDA 510(k) clearance. It is intended for use on adult patients and is supplied by Invacare Corp.
Frequently asked questions
What is the intended use of the Twilight II Nasal Mask?
This device is a non-continuous ventilator accessory designed for use with positive airway pressure devices, such as CPAP. It is specifically indicated for the treatment of adult obstructive sleep apnea in patients weighing over 30 kg.
Does the mask include features for monitoring pressure?
Yes, the mask features a port located on the mask swivel. This port is designed to facilitate pressure measurement during therapy.
What is the regulatory status of this device?
The Twilight II Nasal Mask is authorized under FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: INVACARE'S TWILIGHT II NASAL MASKS by INVACARE CORP. | FDA 510 (k) Summary, PDF Invacare TwilightTMII Nasal Mask, Invacare – Wikipedia, Twilight II Nasal Mask - Invacare | Flagship Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061874 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K061874 24 fields · synced Sep 22, 2026