FDA 510(k) Application Details - K080250

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K080250
Device Name	Neurological Stereotaxic Instrument
Applicant	ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 STOCKHOLM S-103 93 SE Other 510(k) Applications for this Company
Contact	PETER LOWENDAHL 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	01/31/2008
Decision Date	05/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review