FDA 510(k) Application Details - K170441

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K170441
Device Name	Electroencephalograph
Applicant	MobileMedTek 1205 E. Washington St., Ste 115 Louisville, KY 40206 US Other 510(k) Applications for this Company
Contact	Bryan Ehret Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2017
Decision Date	06/05/2017
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