FDA 510(k) Application Details - K210289

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K210289
Device Name	Unit, Neonatal Phototherapy
Applicant	Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam-si 13201 KR Other 510(k) Applications for this Company
Contact	Dae Eun Kim 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	02/02/2021
Decision Date	05/28/2021
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	Y
Expedited Review