K-number	K230632
Device name	VersiHD with GuideMe software
Applicant	Nxstage Medical, Inc.
Product code	KDI
Device class	Class II
Decision date	Aug 11, 2023
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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VersiHD with GuideMe software

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