K-number	K233335
Device name	Tablo® Hemodialysis System
Applicant	Outset Medical, Inc.
Product code	KDI
Device class	Class II
Decision date	Dec 5, 2023
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Tablo® Hemodialysis System

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