Name: Predicase
Price: 199 USD

K-number	K113451
Device name	NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
Applicant	Nidek Technologies Srl
Product code	HKI
Device class	Class II
Decision date	May 8, 2012
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 AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

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