FDA 510(k) Application Details - K242604

Device Classification Name	More FDA Info for this Device
510(K) Number	K242604
Device Name	Helios+ UV-C System
Applicant	PreventaMed Technologies, Inc. dba Surfacide Manufacturing W226N918 Northmound Drive, Suite 300 Waukesha, WI 53186 US Other 510(k) Applications for this Company
Contact	Jeffry Veenhuis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2024
Decision Date	05/27/2025
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