K-number	K231901
Device name	Hakon, Hakon Smart
Applicant	Medical San Indústria DE Equipamentos Médicos Ltda.
Product code	GEX
Device class	Class II
Decision date	Sep 28, 2023
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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Hakon, Hakon Smart

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