K-number	K210197
Device name	NFC-600 Automated Portable Retinal Camera
Applicant	Crystalvue Medical Corporation
Product code	HKI
Device class	Class II
Decision date	Apr 13, 2021
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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NFC-600 Automated Portable Retinal Camera

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