FDA 510(k) Application Details - K113785

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K113785
Device Name	Stimulator, Photic, Evoked Response
Applicant	ANSCHEL TECHNOLOGY, INC. 261 MADISON AVENUE, 24TH FLOOR NEW YORK, NY 10016 US Other 510(k) Applications for this Company
Contact	GLEN PARK Other 510(k) Applications for this Contact
Regulation Number	882.1890   More FDA Info for this Regulation Number
Classification Product Code	GWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2011
Decision Date	06/06/2012
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