FDA 510(k) Application Details - K964801

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K964801
Device Name	Neurological Stereotaxic Instrument
Applicant	RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. BURLINGTON, MA 01803-0658 US Other 510(k) Applications for this Company
Contact	AMY J LAFORTE, PH.D. 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	11/29/1996
Decision Date	06/02/1997
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