Canon Non-mydriatic Retinal Camera CR Series

Camera, Ophthalmic, Ac-powered

Canon Inc.

The following data is part of a premarket notification filed by Canon Inc. with the FDA for Canon Non-mydriatic Retinal Camera Cr Series.

Pre-market Notification Details

Device IDK201122
510k NumberK201122
Device Name:Canon Non-mydriatic Retinal Camera CR Series
ClassificationCamera, Ophthalmic, Ac-powered
Applicant Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki,  JP 211-8501
ContactAkira Hirai
CorrespondentAkira Hirai
Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki,  JP 211-8501
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2020-07-23

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