FDA product code QNZ: Powered Communication System For Emergency Use
QNZ is the FDA product code for powered communication system for emergency use. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QNZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Powered Communication System For Emergency Use |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QNZ devices
openFDA lists no recalls for product code QNZ.
Frequently asked questions
What is FDA product code QNZ?
QNZ is the FDA product code for powered communication system for emergency use. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QNZ?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QNZ
- Run a recall and safety report across every QNZ manufacturer
- Watch product code QNZ 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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