FDA 510(k) Application Details - K163448

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K163448
Device Name	Device, Biofeedback
Applicant	SUNSTAR SUISSE S.A. Route de Pallatex 11 Etoy 1163 CH Other 510(k) Applications for this Company
Contact	Olivier Ducamp Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	09/01/2017
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