The following data is part of a premarket notification filed by Eye Tel Imaging, Inc. with the FDA for Digiscope Ophthalmic Camera.
| Device ID | K990205 |
| 510k Number | K990205 |
| Device Name: | DIGISCOPE OPHTHALMIC CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | EYE TEL IMAGING, INC. 15078 STILLFIELD PLACE Centreville, VA 20120 |
| Contact | Kevin T Quinn |
| Correspondent | Kevin T Quinn EYE TEL IMAGING, INC. 15078 STILLFIELD PLACE Centreville, VA 20120 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-03-26 |
| Summary: | summary |