FDA 510(k) Application Details - K200031

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K200031
Device Name	Unit, Neonatal Phototherapy
Applicant	Avalon Biomedical (Shenzhen) Limited 805 Building 4, Yinxing Zhijie, 1301-74, GuanGuang Road, XinLan Community, GuanLan Street, Longhua District 518110 CN Other 510(k) Applications for this Company
Contact	Eva Zhu 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	01/07/2020
Decision Date	10/05/2020
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