K-number	K222727
Device name	i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
Applicant	I3 Membrane GmbH
Product code	NHV
Device class	Class II
Decision date	Jun 2, 2023
Decision	Substantially Equivalent
Regulation	876.5665

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View the full FDA submission: accessdata.fda.gov

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i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

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