FDA 510(k) Application Details - K133980

Device Classification Name	Stimulator, Electro-Acupuncture   More FDA Info for this Device
510(K) Number	K133980
Device Name	Stimulator, Electro-Acupuncture
Applicant	PANTHEON RESEARCH 1468 HARWELL AVE CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLANDA SMITH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	BWK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2013
Decision Date	11/07/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review