K-number	K230341
Device name	ACRIFIX
Applicant	Deltamed GmbH
Product code	EBI
Device class	Class II
Decision date	Apr 6, 2023
Decision	Substantially Equivalent
Regulation	872.3760

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Source

View the full FDA submission: accessdata.fda.gov

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ACRIFIX

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