FDA product code QWX: Active Noise Attenuation System For Infant Incubators
QWX is the FDA product code for active noise attenuation system for infant incubators. It is a Class II device, regulated under 21 CFR 880.5405 and reviewed by the General Hospital panel. Devices under QWX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.
Classification
| Field | Value |
|---|---|
| Device name | Active Noise Attenuation System For Infant Incubators |
| Device class | Class II |
| Regulation | 21 CFR 880.5405 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QWX devices
openFDA lists no recalls for product code QWX.
Frequently asked questions
What is FDA product code QWX?
QWX is the FDA product code for active noise attenuation system for infant incubators. It is a Class II device, regulated under 21 CFR 880.5405 and reviewed by the General Hospital panel.
What device class is QWX?
Class II, regulation 21 CFR 880.5405. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QWX
- Run a recall and safety report across every QWX manufacturer
- Watch product code QWX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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