FDA 510(k) Application Details - K122125

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K122125
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE CALENZANO 50041 IT Other 510(k) Applications for this Company
Contact	PAOLO PERUZZI 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	07/18/2012
Decision Date	01/25/2013
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	N
Expedited Review