TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

Camera, Ophthalmic, Ac-powered

TOPCON CORPORATION

The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Trc-nw400 Non-mydriatic Retinal Camera.

Pre-market Notification Details

Device IDK141481
510k NumberK141481
Device Name:TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
ClassificationCamera, Ophthalmic, Ac-powered
Applicant TOPCON CORPORATION 5 TIMBER LANE North Reading,  MA  01864
ContactMaureen O'connell
CorrespondentMaureen O'connell
TOPCON CORP. 5 TIMBER LANE North Reading,  MA  01864
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-04
Decision Date2014-09-17
Summary:summary

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