FDA 510(k) Application Details - K192234

Device Classification Name	More FDA Info for this Device
510(K) Number	K192234
Device Name	ActiPatch
Applicant	BioElectronics Corporation 4539 Metropolitan Ct Frederick, MD 21704 US Other 510(k) Applications for this Company
Contact	Sree N. Koneru Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2019
Decision Date	01/31/2020
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