K080883 is an FDA 510(k) clearance for the CR-1. 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 April 24, 2008, 24 days after receiving the submission on March 31, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K080883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2008 |
| Decision Date | April 24, 2008 |
| Days to Decision | 24 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 |