FDA 510(k) Application Details - K081835

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K081835
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	BIOINDUCTION LIMITED 2300 MCDERMOTT ROAD SUITE 200-207 PLANO, TX 75025 US Other 510(k) Applications for this Company
Contact	KRISTA OAKES Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2008
Decision Date	03/19/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review