K-number	K243273
Device name	CeQur Simplicity On-Demand Insulin Delivery System
Applicant	Cequr SA
Product code	OPP
Device class	Class II
Decision date	Nov 13, 2024
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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CeQur Simplicity On-Demand Insulin Delivery System

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CeQur Simplicity On-Demand Insulin Delivery System