FDA 510(k) Application Details - K991012

Device Classification Name	Non-Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K991012
Device Name	Non-Normalizing Quantitative Electroencephalograph Software
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	PENELOPE H GRECO 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	03/26/1999
Decision Date	06/24/1999
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