FDA 510(k) Applications for Medical Device Product Code: OPP (Pump, Infusion, Insulin Bolus)

FDA 510(k) Applications for Medical Device Product Code "OPP"
(Pump, Infusion, Insulin Bolus)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K111924	CALIBRA MEDICAL, INC.	FINESSE PERSONAL INSULIN DELIVERY PATCH	04/10/2012
K100947	CALIBRA MEDICAL, INC.	FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000	06/28/2010
K093065	CALIBRA MEDICAL, INC.	FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000	01/20/2010
K233447	CeQur SA	CeQur SimplicityÖ On-Demand Insulin Delivery System	01/18/2024
K243273	CeQur SA	CeQur SimplicityÖ On-Demand Insulin Delivery System	11/13/2024
K163357	LifeScan Europe, a division of Cilag GmbH	OneTouch Via On-Demand Insulin Delivery System	06/07/2017