FDA 510(k) Application Details - K162240

Device Classification Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K162240
Device Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant	PROMEDTEK INC. 4110 N. SCOTTSDALE RD., SUITE 270 Scottsdale, AZ 85251 US Other 510(k) Applications for this Company
Contact	Dan Puchek Other 510(k) Applications for this Contact
Regulation Number	890.5290   More FDA Info for this Regulation Number
Classification Product Code	IMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2016
Decision Date	11/17/2016
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