K-number	K210900
Device name	Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Applicant	Canon Medical Systems Corporation
Product code	OWB
Device class	Class II
Decision date	Apr 12, 2021
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

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