FDA 510(k) Application Details - K093618

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K093618
Device Name	Unit, Neonatal Phototherapy
Applicant	PHYSICIAN ENGINEERED PRODUCTS, INC. 103 SMITH ST. FRYEBURG, ME 04037 US Other 510(k) Applications for this Company
Contact	ROB ROSE, MD 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	11/23/2009
Decision Date	04/23/2010
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