CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, And GANGLION CELL NORMATIVE DATABASES

Tomography, Optical Coherence

CARL ZEISS MEDITEC INC

The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Cirrus Hd-oct With Retinal Nerve Fiber Layer, Macular, Optic Nerve Head, And Ganglion Cell Normative Databases.

Pre-market Notification Details

Device IDK111157
510k NumberK111157
Device Name:CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, And GANGLION CELL NORMATIVE DATABASES
ClassificationTomography, Optical Coherence
Applicant CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin,  CA  94568
ContactJudith A Brimacombe
CorrespondentJudith A Brimacombe
CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin,  CA  94568
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-25
Decision Date2012-01-19
Summary:summary

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