The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Retina Workplace.
| Device ID | K170638 |
| 510k Number | K170638 |
| Device Name: | Retina Workplace |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Dong Hua Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-02 |
| Decision Date | 2017-06-21 |
| Summary: | summary |