The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Visante Oct.
| Device ID | K051789 |
| 510k Number | K051789 |
| Device Name: | VISANTE OCT |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-09-30 |
| Summary: | summary |