FDA 510(k) Application Details - K240148

Device Classification Name	More FDA Info for this Device
510(K) Number	K240148
Device Name	SCIg60 Infusion System
Applicant	EMED Technologies Corporation 1262 Hawks Flight Court Suite 200 EL Dorado Hills, CA 95762 US Other 510(k) Applications for this Company
Contact	Olena Whalen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2024
Decision Date	02/16/2024
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