GDXPRO

Ophthalmoscope, Laser, Scanning

CARL ZEISS MEDITEC INC

The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Gdxpro.

Pre-market Notification Details

Device IDK093521
510k NumberK093521
Device Name:GDXPRO
ClassificationOphthalmoscope, Laser, Scanning
Applicant CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin,  CA  94551
ContactJudy A Brimacombe
Product CodeMYC  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-11-13
Decision Date2009-11-25
Summary:summary

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