K041546 is an FDA 510(k) clearance for the DIGITAL FUNDUS CAMERA, MODEL CF-60DSI. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Canon, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 23, 2004, 14 days after receiving the submission on June 9, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K041546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2004 |
| Decision Date | June 23, 2004 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI — Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |