FITE FIXATION TOY FOR OCULAR EXAM
Device Facts
| Record ID | K801381 |
|---|---|
| Device Name | FITE FIXATION TOY FOR OCULAR EXAM |
| Applicant | Fite Engineering Corp. |
| Product Code | HPL · Ophthalmic |
| Decision Date | Jul 28, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1290 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)
