The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Callisto Eye.
Device ID | K123464 |
510k Number | K123464 |
Device Name: | CALLISTO EYE |
Classification | System, Image Management, Ophthalmic |
Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
Contact | Judy Brimacombe |
Correspondent | Judy Brimacombe CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
Product Code | NFJ |
Subsequent Product Code | EPT |
Subsequent Product Code | HMR |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-09 |
Decision Date | 2013-03-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CALLISTO EYE 77495432 3660054 Live/Registered |
Carl Zeiss AG 2008-06-10 |