The following data is part of a premarket notification filed by Ophthalmic Imaging Systems with the FDA for Glaucoma-scope.
| Device ID | K913118 |
| 510k Number | K913118 |
| Device Name: | GLAUCOMA-SCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Contact | Steven R Verdooner |
| Correspondent | Steven R Verdooner OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-15 |
| Decision Date | 1991-10-09 |