The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc with the FDA for Retina Workplace.
| Device ID | K182318 |
| 510k Number | K182318 |
| Device Name: | Retina Workplace |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Carl Zeiss Meditec, Inc 5160 Hacienda Drive Dublin, CA 94568 |
| Contact | Maria Golovina |
| Correspondent | Maria Golovina Carl Zeiss Meditec, Inc 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | NFJ |
| Subsequent Product Code | HKI |
| Subsequent Product Code | OBO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2018-10-24 |
| Summary: | summary |