FDA 510(k) Application Details - K123972

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K123972
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY SUITE 150 AUSTIN, TX 78746-3211 US Other 510(k) Applications for this Company
Contact	GLEN NEALLY Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	04/01/2013
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