FDA 510(k) Application Details - K143487

Device Classification Name	Non-Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K143487
Device Name	Non-Normalizing Quantitative Electroencephalograph Software
Applicant	KVIKNA EHF STORHOFOI 21 REYKJAVIK 110 IS Other 510(k) Applications for this Company
Contact	Gardar Thorvardsson Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2014
Decision Date	08/21/2015
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