FDA 510(k) Application Details - K150353

Device Classification Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K150353
Device Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant	BTL INDUSTRIES, INC 47 Loring Drive Framingham, MA 01702 US Other 510(k) Applications for this Company
Contact	Jan Zarsky Other 510(k) Applications for this Contact
Regulation Number	890.5860   More FDA Info for this Regulation Number
Classification Product Code	IMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2015
Decision Date	11/13/2015
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