HLA · Calibrator, Tonometer
Ophthalmic · 21 CFR 886.1930 · Class 2
Overview
| Product Code | HLA |
|---|---|
| Device Name | Calibrator, Tonometer |
| Regulation | 21 CFR 886.1930 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
