FDA 510(k) Application Details - K042391

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K042391
Device Name	Neurological Stereotaxic Instrument
Applicant	BRAINLAB AG AMMERTHALSTRASSE 8 HEIMSTETTEN 85551 DE Other 510(k) Applications for this Company
Contact	JENS WITTE 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	09/02/2004
Decision Date	10/19/2004
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