FDA 510(k) Application Details - K033340

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K033340
Device Name	Neurological Stereotaxic Instrument
Applicant	ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 PO BOX 7593 STOCKHOLM SE-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	10/17/2003
Decision Date	02/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review