K-number	K232767
Device name	Nautilus VF ECMO Oxygenator
Applicant	Mc3, Inc.
Product code	BYS
Device class	Class II
Decision date	Oct 4, 2023
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Nautilus VF ECMO Oxygenator

Everything you need for a 510(k) submission. Nothing you don't.