DRSplus

Ophthalmoscope, Laser, Scanning

CenterVue SpA

The following data is part of a premarket notification filed by Centervue Spa with the FDA for Drsplus.

Pre-market Notification Details

Device IDK192113
501k NumberK192113
Device Name:DRSplus
ClassificationOphthalmoscope, Laser, Scanning
Applicant CenterVue SpA Via S. Marco 9H Padova,  IT 35129
ContactRoberto Gabriotti
CorrespondentRoberto Gabriotti
CenterVue SpA Via S. Marco 9H Padova,  IT 35129
Product CodeMYC  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
501k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2019-11-15

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