FDA 510(k) Application Details - K182363

Device Classification Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K182363
Device Name	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant	BTL Industries, Inc. 362 Elm Street Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	David Chmel 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	08/30/2018
Decision Date	01/24/2019
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