HLT · Preamplifier, Ac-Powered, Ophthalmic
Ophthalmic · 21 CFR 886.1640 · Class 2
Overview
| Product Code | HLT |
|---|---|
| Device Name | Preamplifier, Ac-Powered, Ophthalmic |
| Regulation | 21 CFR 886.1640 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | Chalgren Enterprises, Inc. | Dec 7, 1994 | SESE |
| K921815 | TOMEY PE-300 PORTABLE ERG | Tomey Corporation USA | Jul 15, 1992 | SESE |
| K841293 | PANORAMIC LOUPES - VARIOUS | Keller Instruments, Inc. | May 9, 1984 | SESE |
| K781543 | ORBIOGRAPH | Sonometrics Systems, Inc. | Oct 24, 1978 | SESE |
Top Applicants
- Chalgren Enterprises, Inc. — 1 clearance
- Keller Instruments, Inc. — 1 clearance
- Sonometrics Systems, Inc. — 1 clearance
- Tomey Corporation USA — 1 clearance
