FDA 510(k) Application Details - K163526

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K163526
Device Name	Unit, Neonatal Phototherapy
Applicant	NEOMEDLIGHT 89-90 Rue Frederic FAYS Villeurbanne 69100 FR Other 510(k) Applications for this Company
Contact	Pierre Saint Girons 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	12/16/2016
Decision Date	10/06/2017
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