FDA 510(k) Application Details - K162683

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K162683
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	HASOMED GmbH Paul-Ecke-Str. 1 Magdeburg 39114 DE Other 510(k) Applications for this Company
Contact	Matthias Ueltzen 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	09/26/2016
Decision Date	02/03/2017
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