FDA 510(k) Application Details - K082707

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K082707
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	MEDX ELECTRONICS, INC. 3350 RIDGEWAY DR. UNIT #3 MISSISSAUGA, ONTARIO L5L 5Z9 CA Other 510(k) Applications for this Company
Contact	ANITA SALTMARCHE 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	09/16/2008
Decision Date	10/01/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review