EIDON FA, EIDON, EIDON AF, EIDON UWFL

Ophthalmoscope, Laser, Scanning

CenterVue SpA

The following data is part of a premarket notification filed by Centervue Spa with the FDA for Eidon Fa, Eidon, Eidon Af, Eidon Uwfl.

Pre-market Notification Details

Device IDK211328
510k NumberK211328
Device Name:EIDON FA, EIDON, EIDON AF, EIDON UWFL
ClassificationOphthalmoscope, Laser, Scanning
Applicant CenterVue SpA Via S. Marco 9H Padova,  IT 35129
ContactLuca Scienza
CorrespondentLuca Scienza
CenterVue SpA Via S. Marco 9H Padova,  IT 35129
Product CodeMYC  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-08-19

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