K-number	K122051
Device name	NXSTAGE SYSTEM ONE
Applicant	Nxstage Medical, Inc.
Product code	KDI
Device class	Class II
Decision date	Apr 23, 2013
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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NXSTAGE SYSTEM ONE

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