The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Forum Glaucoma Workplace.
Device ID | K141297 |
510k Number | K141297 |
Device Name: | FORUM GLAUCOMA WORKPLACE |
Classification | System, Image Management, Ophthalmic |
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 | NFJ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-19 |
Decision Date | 2014-10-03 |
Summary: | summary |