FDA 510(k) Application Details - K050313

Device Classification Name	Pinwheel   More FDA Info for this Device
510(K) Number	K050313
Device Name	Pinwheel
Applicant	ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. NEWTON, MA 02464 US Other 510(k) Applications for this Company
Contact	CHRISTINE VOZELLA Other 510(k) Applications for this Contact
Regulation Number	882.1750   More FDA Info for this Regulation Number
Classification Product Code	GWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2005
Decision Date	02/24/2005
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