FDA 510(k) Application Details - K130866

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K130866
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	BIOLIGHT AB WARFVINGES VAG 26 STOCKHOLM SE 112 51 SE Other 510(k) Applications for this Company
Contact	PAR OLAUSSON LIDO Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	ILY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2013
Decision Date	10/25/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review