The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Retina Workplace.
| Device ID | K150467 |
| 510k Number | K150467 |
| Device Name: | Retina Workplace |
| Classification | System, Image Management, Ophthalmic |
| Applicant | CARL ZEISS MEDITEC AG GOESCHWITZER STR. 51-52 Jena, DE 07745 |
| Contact | Michael Haisch |
| Correspondent | Christine Dunbar 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 | 2015-02-23 |
| Decision Date | 2015-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471070118 | K150467 | 000 |