FDA product code QOU: Emergency Resuscitator
QOU is the FDA product code for emergency resuscitator. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under QOU reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Emergency Resuscitator |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOU devices
openFDA lists no recalls for product code QOU.
Frequently asked questions
What is FDA product code QOU?
QOU is the FDA product code for emergency resuscitator. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is QOU?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOU
- Run a recall and safety report across every QOU manufacturer
- Watch product code QOU 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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