FDA 510(k) Application Details - K233447

Device Classification Name	Pump, Infusion, Insulin Bolus   More FDA Info for this Device
510(K) Number	K233447
Device Name	Pump, Infusion, Insulin Bolus
Applicant	CeQur SA Ebenaustrasse 10 Horw Luzern 6048 CH Other 510(k) Applications for this Company
Contact	Michael Simpson Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	OPP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2023
Decision Date	01/18/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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