CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

Camera, Ophthalmic, Ac-powered

CENTERVUE SPA

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

Pre-market Notification Details

Device IDK101935
510k NumberK101935
Device Name:CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
ClassificationCamera, Ophthalmic, Ac-powered
Applicant CENTERVUE SPA PIAZZA ALBANIA 10 Rome,  IT 00153
ContactRoger Gray
CorrespondentRoger Gray
CENTERVUE SPA PIAZZA ALBANIA 10 Rome,  IT 00153
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-12
Decision Date2010-10-27
Summary:summary

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