FDA 510(k) Application Details - K102051

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K102051
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 VISTA, CA 92085-1360 US Other 510(k) Applications for this Company
Contact	GARY BUSSETT Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2010
Decision Date	07/29/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review