FDA 510(k) Application Details - K110550

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K110550
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	ROBERT ROSE 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	02/25/2011
Decision Date	02/03/2012
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