FORUM GLAUCOMA WORKPLACE

System, Image Management, Ophthalmic

CARL ZEISS MEDITEC AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Forum Glaucoma Workplace.

Pre-market Notification Details

Device IDK130648
510k NumberK130648
Device Name:FORUM GLAUCOMA WORKPLACE
ClassificationSystem, Image Management, Ophthalmic
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactMandy Ambrecht
CorrespondentMandy Ambrecht
CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-11
Decision Date2013-07-23
Summary:summary

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