The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Non-mydriatic Retinal Camera, Model Cr-dgi.
| Device ID | K031629 |
| 510k Number | K031629 |
| Device Name: | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Sheila Driscoll |
| Correspondent | Kent Donohue UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-06-06 |
| Summary: | summary |