K-number	K222471
Device name	IRRAflow Active Fluid Exchange System (AFES)
Applicant	Irras USA
Product code	JXG
Device class	Class II
Decision date	Dec 8, 2022
Decision	Substantially Equivalent
Regulation	882.5550

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View the full FDA submission: accessdata.fda.gov

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IRRAflow Active Fluid Exchange System (AFES)

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