Name: Predicase
Price: 199 USD

K-number	K131908
Device name	2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KDI
Device class	Class II
Decision date	Oct 11, 2013
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)

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