K-number	K232926
Device name	Novalung ultimate kit (US)
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	QJZ
Device class	Class II
Decision date	Apr 15, 2024
Decision	Substantially Equivalent
Regulation	870.4100

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Source

View the full FDA submission: accessdata.fda.gov

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Novalung ultimate kit (US)

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