FDA 510(k) Application Details - K232316

Device Classification Name	Controller, Infusion, Intravascular, Electronic   More FDA Info for this Device
510(K) Number	K232316
Device Name	Controller, Infusion, Intravascular, Electronic
Applicant	DEKA Research and Development 340 Commercial Street Manchester, NH 03101 US Other 510(k) Applications for this Company
Contact	Paul Smolenski Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2023
Decision Date	03/01/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review