K-number	K221919
Device name	DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Applicant	Hemodia Sas
Product code	HRX
Device class	Class II
Decision date	Mar 9, 2023
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

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