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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
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