FDA 510(k) Application Details - K171446

Device Classification Name	More FDA Info for this Device
510(K) Number	K171446
Device Name	Cefaly Acute
Applicant	CEFALY Technology Rue Louis Plescia 34 Seraing 4102 BE Other 510(k) Applications for this Company
Contact	Jean-Yves Mignolet Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2017
Decision Date	09/15/2017
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