FDA product code NVB: Intraocular, Pressure Measuring Device
NVB is the FDA product code for intraocular, pressure measuring device. It is a Class III device, regulated under 21 CFR 886.4280 and reviewed by the Ophthalmic panel. Devices under NVB reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
Classification
| Field | Value |
|---|---|
| Device name | Intraocular, Pressure Measuring Device |
| Device class | Class III |
| Regulation | 21 CFR 886.4280 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for NVB devices
openFDA lists no recalls for product code NVB.
Frequently asked questions
What is FDA product code NVB?
NVB is the FDA product code for intraocular, pressure measuring device. It is a Class III device, regulated under 21 CFR 886.4280 and reviewed by the Ophthalmic panel.
What device class is NVB?
Class III, regulation 21 CFR 886.4280. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NVB
- Run a recall and safety report across every NVB manufacturer
- Watch product code NVB 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.