FDA product code ETM: Gustometer, Sterile
ETM is the FDA product code for gustometer, sterile. It is a Class I device, regulated under 21 CFR 874.1500 and reviewed by the Ear, Nose and Throat panel. Devices under ETM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gustometer, 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 |
Recalls for ETM devices
openFDA lists no recalls for product code ETM.
Frequently asked questions
What is FDA product code ETM?
ETM is the FDA product code for gustometer, 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 ETM?
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 ETM
- Run a recall and safety report across every ETM manufacturer
- Watch product code ETM 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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