K-number	K222952
Device name	2008T BlueStar Hemodailysis Machine
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KDI
Device class	Class II
Decision date	Oct 27, 2022
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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2008T BlueStar Hemodailysis Machine

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