FDA 510(k) Application Details - K002330

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K002330
Device Name	Endoscope, Neurological
Applicant	IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. MELBOURNE, FL 32935 US Other 510(k) Applications for this Company
Contact	DAVID M LEE Other 510(k) Applications for this Contact
Regulation Number	882.1480   More FDA Info for this Regulation Number
Classification Product Code	GWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2000
Decision Date	10/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review