iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241469 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
- Models / Variants
- iQ 2 Nasal Vented Mask FDA 510(k)Phantom 2 Nasal Vented Mask 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 iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are nasal masks designed for sleep apnea therapy. These masks feature interchangeable cushions and can be shaped to accommodate individual facial structures and night-to-night variations. The masks are designed to provide a personalized fit with better visibility for the user.
The masks are supplied with interchangeable cushions and use the same mask frame and headgear. They are lightweight and designed to fit most facial features. The device has received FDA 510(k) clearance with the product code BZD and is classified as a ventilator, non-continuous (respirator) in the medical specialty of anesthesiology.
Frequently asked questions
What is the iQ 2 Nasal Vented Mask used for?
The iQ 2 Nasal Vented Mask is designed for sleep apnea therapy. It features interchangeable cushions that can be shaped to accommodate individual facial structures and night-to-night variations, providing a personalized fit with better visibility for the user.
What is included with the iQ 2 Nasal Vented Mask?
The masks are supplied with interchangeable cushions and use the same mask frame and headgear. They are lightweight and designed to fit most facial features, making them versatile for different users.
What is the regulatory status of the iQ 2 Nasal Vented Mask?
The device has received FDA 510(k) clearance with the product code BZD and is classified as a ventilator, non-continuous (respirator) in the medical specialty of anesthesiology. This clearance indicates it meets the necessary safety and effectiveness requirements.
How does the interchangeable cushion system work?
The interchangeable cushion system allows users to customize their mask fit to accommodate individual facial structures and night-to-night variations. This feature enhances comfort and effectiveness by providing a more personalized seal for sleep apnea therapy.
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: iQ®2 Nasal Mask - Sleepnet Corporation Sleep Apnea CPAP Masks, Sleepnet Phantom®2 Nasal Mask - CPAP mask with Replaceable Cushions, CM049 Sleepnet® iQ®2 Nasal Vented Mask - Sunset Healthcare Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241469 | Class II | Active |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
Sources (1)
- FDA 510(k) K241469 24 fields · synced Oct 1, 2026