K-number	K230919
Device name	Acumen IQ finger cuff
Applicant	Edwards Lifesciences, LLC
Product code	DXN
Device class	Class II
Decision date	Oct 24, 2023
Decision	Substantially Equivalent
Regulation	870.1130

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Source

View the full FDA submission: accessdata.fda.gov

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Acumen IQ finger cuff

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