FDA 510(k) Application Details - K161628

Device Classification Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K161628
Device Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant	Bonutti Research, Inc. P.O. Box 1367 Effingham, IL 62401 US Other 510(k) Applications for this Company
Contact	Patrick G. Balsmann Other 510(k) Applications for this Contact
Regulation Number	890.5300   More FDA Info for this Regulation Number
Classification Product Code	IMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2016
Decision Date	11/10/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review