K-number	K221111
Device name	Non-Mydriatic Retinal Camera NW500
Applicant	Topcon Corporation
Product code	HKI
Device class	Class II
Decision date	Aug 29, 2022
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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Non-Mydriatic Retinal Camera NW500

Everything you need for a 510(k) submission. Nothing you don't.