K-number	K113427
Device name	FRESENIUS 2008T HEMODIALYSIS MACHINE
Applicant	Fresenius Medical Care North America
Product code	KDI
Device class	Class II
Decision date	Dec 21, 2011
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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FRESENIUS 2008T HEMODIALYSIS MACHINE

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