BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
Device Facts
| Record ID | K934084 |
|---|---|
| Device Name | BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE |
| Applicant | Bioenterics Corp. |
| Product Code | HMJ · Ophthalmic |
| Decision Date | Dec 16, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1810 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
