FDA 510(k) Application Details - K101627

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K101627
Device Name	Neurological Stereotaxic Instrument
Applicant	BRAINLAB AG KAPELLENSTRASSE 12 FELDKIRCHEN 85622 DE Other 510(k) Applications for this Company
Contact	ALEXANDER SCHWIERSCH 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	06/09/2010
Decision Date	06/03/2011
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