BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
Device Facts
| Record ID | K000544 |
|---|---|
| Device Name | BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 |
| Applicant | Labtician Ophthalmics, Inc. |
| Product Code | HJX · Ophthalmic |
| Decision Date | Mar 9, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5810 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.
