The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Cirrus Photo.
Device ID | K133217 |
510k Number | K133217 |
Device Name: | CIRRUS PHOTO |
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 | 2013-10-18 |
Decision Date | 2014-03-19 |
Summary: | summary |