K-number	K200688
Device name	hyperion X5, NewTom GO, X-RADiUS COMPACT
Applicant	Cefla S.C.
Product code	OAS
Device class	Class II
Decision date	Apr 9, 2020
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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hyperion X5, NewTom GO, X-RADiUS COMPACT

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