K-number	K182199
Device name	NFC-700 non-mydriatic auto fundus camera
Applicant	Crystalvue Medical Corporation
Product code	HKI
Device class	Class II
Decision date	Jan 2, 2019
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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NFC-700 non-mydriatic auto fundus camera

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