FDA 510(k) Application Details - K092625

Device Classification Name	More FDA Info for this Device
510(K) Number	K092625
Device Name	WAVESTATE NEUROMONITOR
Applicant	WAVESTATE INC 1468 HARWELL AVE CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2009
Decision Date	06/29/2010
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	Y
Expedited Review