MONOPOLAR NEEDLE ELECTRODE
Device Facts
| Record ID | K900098 |
|---|---|
| Device Name | MONOPOLAR NEEDLE ELECTRODE |
| Applicant | Oculinum, Inc. |
| Product Code | HLW · Ophthalmic |
| Decision Date | Feb 9, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1640 |
| Device Class | Class 2 |
Regulatory Classification
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).
