K-number	K230612
Device name	Edwards Algorithm for Measurement of Blood Hemoglobin
Applicant	Edwards Lifesciences, LLC
Product code	MUD
Device class	Class II
Decision date	Nov 17, 2023
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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Edwards Algorithm for Measurement of Blood Hemoglobin

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