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 |