The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visucam Pro Nm.
| Device ID | K052268 |
| 510k Number | K052268 |
| Device Name: | VISUCAM PRO NM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Kent W Jones |
| Correspondent | Kent W Jones CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-19 |
| Decision Date | 2005-11-02 |
| Summary: | summary |