K-number	K223794
Device name	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Applicant	Cefla S.C.
Product code	OAS
Device class	Class II
Decision date	Jan 17, 2023
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

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