K-number	K231534
Device name	5008X Hemodialysis System
Applicant	Fresenius Medical Care
Product code	KDI
Device class	Class II
Decision date	Feb 2, 2024
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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5008X Hemodialysis System

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