K043222 is an FDA 510(k) clearance for the VISCUCAM C DIGITAL CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on February 14, 2005, 84 days after receiving the submission on November 22, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K043222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2004 |
| Decision Date | February 14, 2005 |
| Days to Decision | 84 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 |