NJJ · Tonometer, Analyzer, Ocular Blood Flow
Ophthalmic · 21 CFR 886.1930 · Class 2
Overview
| Product Code | NJJ |
|---|---|
| Device Name | Tonometer, Analyzer, Ocular Blood Flow |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Paradigm Medical Industries, Inc. | Oct 21, 2002 | SESE |
Top Applicants
- Paradigm Medical Industries, Inc. — 1 clearance
