FDA 510(k) Application Details - K242752

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K242752
Device Name	Pump, Infusion
Applicant	Iradimed Corporation 1025 Willa Springs Drive Winter Springs, FL 32708 US Other 510(k) Applications for this Company
Contact	Steven Kachelmeyer 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	09/12/2024
Decision Date	05/28/2025
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