CALLISTO Eye
System, Image Management, Ophthalmic
Carl Zeiss Meditec AG
The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Callisto Eye.
Pre-market Notification Details
| Device ID | K180858 |
| 510k Number | K180858 |
| Device Name: | CALLISTO Eye |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Mandy Ambrecht 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 | 2018-04-02 |
| Decision Date | 2018-06-27 |
| Summary: | summary |
Trademark Results [CALLISTO Eye]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALLISTO EYE 77495432 3660054 Live/Registered |
Carl Zeiss AG 2008-06-10 |
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