FDA 510(k) Application Details - K011971

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K011971
Device Name	Neurological Stereotaxic Instrument
Applicant	IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 MELBOURNE, FL 32935 US Other 510(k) Applications for this Company
Contact	DAVID M LEE Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2001
Decision Date	08/03/2001
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