FDA 510(k) Application Details - K242735

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K242735
Device Name	Pump, Infusion
Applicant	Belmont Medical Technologies 780 Boston Road Billerica, MA 01821 US Other 510(k) Applications for this Company
Contact	Lida Reed 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	09/11/2024
Decision Date	12/23/2024
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