The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Forum Glaucoma Workplace.
| Device ID | K130648 |
| 510k Number | K130648 |
| Device Name: | FORUM GLAUCOMA WORKPLACE |
| Classification | System, Image Management, Ophthalmic |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Mandy Ambrecht |
| Correspondent | Mandy Ambrecht CARL ZEISS MEDITEC AG 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 | 2013-03-11 |
| Decision Date | 2013-07-23 |
| Summary: | summary |