TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

Camera, Ophthalmic, Ac-powered

TOPCON CORP.

The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Topcon Model Trc-nw200 Non-mydriatic Retinal Camera.

Pre-market Notification Details

Device IDK041367
510k NumberK041367
Device Name:TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
ClassificationCamera, Ophthalmic, Ac-powered
Applicant TOPCON CORP. 37 WEST CENTURY RD. Paramus,  NJ  07652
ContactDonald H Winfield
CorrespondentDonald H Winfield
TOPCON CORP. 37 WEST CENTURY RD. Paramus,  NJ  07652
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-24
Decision Date2004-11-05
Summary:summary

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