K-number	K190793
Device name	Tablo Hemodialysis System, Tablo Cartridge
Applicant	Outset Medical, Inc.
Product code	KDI
Device class	Class II
Decision date	Dec 12, 2019
Decision	Substantially Equivalent
Regulation	876.5860

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View the full FDA submission: accessdata.fda.gov

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Tablo Hemodialysis System, Tablo Cartridge

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