FDA 510(k) Application Details - K111555

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K111555
Device Name	Stimulator, Auditory, Evoked Response
Applicant	R & D MEDICAL PRODUCTS, INC. 20492 CRESCENT BAY DR. #106 LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	JAMES PERRAULT Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2011
Decision Date	07/25/2011
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