FDA 510(k) Application Details - K250357

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K250357
Device Name	Pump, Infusion
Applicant	DEKA Research & Development Corp. 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	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2025
Decision Date	03/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review