NVB · Intraocular, Pressure Measuring Device
Ophthalmic · 21 CFR 886.4280 · Class 3
Overview
| Product Code | NVB |
|---|---|
| Device Name | Intraocular, Pressure Measuring Device |
| Regulation | 21 CFR 886.4280 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
Identification
An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.