K-number	DEN180055
Device name	CARPEDIEM System
Applicant	Bellco Srl (Now Part of Medtronic, Inc)
Product code	QIR
Device class	Class II
Decision date	Apr 29, 2020
Decision	Not Substantially Equivalent
Regulation	876.5861

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Source

View the full FDA submission: accessdata.fda.gov

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CARPEDIEM System

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