FDA product code ETR: Adaptor, Short Increment Sensitivity Index (Sisi)
ETR is the FDA product code for adaptor, short increment sensitivity index (sisi). It is a Class I device, regulated under 21 CFR 874.1070 and reviewed by the Ear, Nose and Throat panel. Devices under ETR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Short Increment Sensitivity Index (Sisi) |
| Device class | Class I |
| Regulation | 21 CFR 874.1070 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for ETR devices
openFDA lists no recalls for product code ETR.
Frequently asked questions
What is FDA product code ETR?
ETR is the FDA product code for adaptor, short increment sensitivity index (sisi). It is a Class I device, regulated under 21 CFR 874.1070 and reviewed by the Ear, Nose and Throat panel.
What device class is ETR?
Class I, regulation 21 CFR 874.1070. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ETR
- Run a recall and safety report across every ETR manufacturer
- Watch product code ETR 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times