FDA 510(k) Application Details - K031149

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K031149
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH SEATTLE, WA 98108 US Other 510(k) Applications for this Company
Contact	EDWARD B. (TED) WEILER Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2003
Decision Date	05/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review