FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH

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 Forum Archive Forum Archive & Viewer Forum Assist Match.

Pre-market Notification Details

Device IDK122938
510k NumberK122938
Device Name:FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
ClassificationSystem, Image Management, Ophthalmic
Applicant CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactJudy Brimacombe
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-09-24
Decision Date2012-11-02
Summary:summary

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