DIGITAL RETINAL CAMERA

Camera, Ophthalmic, Ac-powered

CANON, INC.

The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Digital Retinal Camera.

Pre-market Notification Details

Device IDK111612
510k NumberK111612
Device Name:DIGITAL RETINAL CAMERA
ClassificationCamera, Ophthalmic, Ac-powered
Applicant CANON, INC. TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGOME 2F Honkomagome, Bunkyo-ku Tokyo,  JP 113-0021
ContactKoji Kubo
CorrespondentKoji Kubo
CANON, INC. TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGOME 2F Honkomagome, Bunkyo-ku Tokyo,  JP 113-0021
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-09
Decision Date2011-09-14
Summary:summary

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