The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Fundus Camera, Model Cf-60dsi.
| Device ID | K041546 |
| 510k Number | K041546 |
| Device Name: | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON INC. ONE CANON PLAZA Lake Success, NY 11042 |
| Contact | Sheila Driscoll |
| Correspondent | Glenn M Luchen 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 | 2004-06-09 |
| Decision Date | 2004-06-23 |
| Summary: | summary |