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 | K141844 |
| 510k Number | K141844 |
| Device Name: | RESCAN 700, CALLISTO EYE |
| Classification | Tomography, Optical Coherence |
| 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 | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-08 |
| Decision Date | 2014-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539102423 | K141844 | 000 |
| 04049539072108 | K141844 | 000 |