FDA product code NFH: Digitizer, Images, Ophthalmic
NFH is the FDA product code for digitizer, images, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2030 and reviewed by the Ophthalmic panel. Devices under NFH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Digitizer, Images, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 892.2030 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for NFH devices
openFDA lists no recalls for product code NFH.
Frequently asked questions
What is FDA product code NFH?
NFH is the FDA product code for digitizer, images, ophthalmic. It is a Class II device, regulated under 21 CFR 892.2030 and reviewed by the Ophthalmic panel.
What device class is NFH?
Class II, regulation 21 CFR 892.2030. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NFH
- Run a recall and safety report across every NFH manufacturer
- Watch product code NFH 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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