K-number	K181804
Device name	Alphenix, INFX-8000C/B, V8.0
Applicant	Canon Medical Systems Corporation
Product code	OWB
Device class	Class II
Decision date	Aug 2, 2018
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, V8.0

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