FDA product code NAN: Tester, Acoustic, Bone Quality
NAN is the FDA product code for tester, acoustic, bone quality. It is a Class III device, reviewed by the Radiology panel. Devices under NAN reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Tester, Acoustic, Bone Quality |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NAN devices
openFDA lists no recalls for product code NAN.
Frequently asked questions
What is FDA product code NAN?
NAN is the FDA product code for tester, acoustic, bone quality. It is a Class III device, reviewed by the Radiology panel.
What device class is NAN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NAN
- Run a recall and safety report across every NAN manufacturer
- Watch product code NAN 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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