The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Rescan 700, Callisto Eye.
| Device ID | K180229 |
| 510k Number | K180229 |
| Device Name: | RESCAN 700, CALLISTO Eye |
| Classification | Tomography, Optical Coherence |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Str. 5 1-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Mandy Ambrecht Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-26 |
| Decision Date | 2019-01-11 |
| Summary: | summary |