FDA 510(k) Application Details - K121123

Device Classification Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K121123
Device Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant	ROCKY MOUNTAIN BIOSYSTEMS, INC. 3930 Youngfield Street Wheat Ridge, CO 80033 US Other 510(k) Applications for this Company
Contact	AMY BENEDICT 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	04/13/2012
Decision Date	03/10/2014
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