Name: Predicase
Price: 199 USD

K-number	K121341
Device name	FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
Applicant	Fresenius Medical Care North America
Product code	KDI
Device class	Class II
Decision date	Dec 6, 2012
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 WITH BIBAG SYSTEM

Everything you need for a 510(k) submission. Nothing you don't.