FDA product code NNJ: Gustometer, Non-Sterile
NNJ is the FDA product code for gustometer, non-sterile. It is a Class I device, regulated under 21 CFR 874.1500 and reviewed by the Ear, Nose and Throat panel. Devices under NNJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gustometer, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.1500 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNJ devices
openFDA lists no recalls for product code NNJ.
Frequently asked questions
What is FDA product code NNJ?
NNJ is the FDA product code for gustometer, non-sterile. It is a Class I device, regulated under 21 CFR 874.1500 and reviewed by the Ear, Nose and Throat panel.
What device class is NNJ?
Class I, regulation 21 CFR 874.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNJ
- Run a recall and safety report across every NNJ manufacturer
- Watch product code NNJ 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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