The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Viscucam C Digital Camera.
| Device ID | K043222 |
| 510k Number | K043222 |
| Device Name: | VISCUCAM C DIGITAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 -7562 |
| Contact | R. Michael Crompton |
| Correspondent | R. Michael Crompton CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 -7562 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-02-14 |
| Summary: | summary |