FDA 510(k) Application Details - K010495

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K010495
Device Name	Unit, Neonatal Phototherapy
Applicant	MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. SAN FERNANDO, CA 91340 US Other 510(k) Applications for this Company
Contact	DAVID GLOVER 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	02/20/2001
Decision Date	03/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review