K-number	DEN200030
Device name	FEops HEARTguide
Applicant	Feops NV
Product code	QQI
Device class	Class II
Decision date	Sep 8, 2021
Decision	Not Substantially Equivalent
Regulation	870.1405

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Source

View the full FDA submission: accessdata.fda.gov

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FEops HEARTguide

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