FDA product code OZQ: Automated Insulin Dosing Device System, Bihormonal Control
OZQ is the FDA product code for automated insulin dosing device system, bihormonal control. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under OZQ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.
Classification
| Field | Value |
|---|---|
| Device name | Automated Insulin Dosing Device System, Bihormonal Control |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OZQ devices
openFDA lists no recalls for product code OZQ.
Frequently asked questions
What is FDA product code OZQ?
OZQ is the FDA product code for automated insulin dosing device system, bihormonal control. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is OZQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OZQ
- Run a recall and safety report across every OZQ manufacturer
- Watch product code OZQ 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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