FDA 510(k) Application Details - K243372

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K243372
Device Name	Unit, Neonatal Phototherapy
Applicant	Gerium Medical, Ltd. 4 Paran St. Building 11 Yavne 8122503 IL Other 510(k) Applications for this Company
Contact	Noam Rubin Tal Other 510(k) Applications for this Contact
Regulation Number	880.5700   More FDA Info for this Regulation Number
Classification Product Code	LBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	05/29/2025
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