K-number	K213523
Device name	X-CUBE i8, X-CUBE i9
Applicant	Alpinion Medical Systems Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Jan 28, 2022
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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X-CUBE i8, X-CUBE i9

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