The following data is part of a premarket notification filed by Ophthalmic Imaging Systems with the FDA for Dfc-1024 & Dfc-512 Digital Imaging System.
| Device ID | K913929 |
| 510k Number | K913929 |
| Device Name: | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM |
| Classification | Camera, Ophthalmic, 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 | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100140 | K913929 | 000 |