DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

Camera, Ophthalmic, Ac-powered

CANON INC.

The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Fundus Camera, Model Cf-60dsi.

Pre-market Notification Details

Device IDK041546
510k NumberK041546
Device Name:DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
ClassificationCamera, Ophthalmic, Ac-powered
Applicant CANON INC. ONE CANON PLAZA Lake Success,  NY  11042
ContactSheila Driscoll
CorrespondentGlenn M Luchen
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-06-09
Decision Date2004-06-23
Summary:summary

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