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FDA 510(k) Application Details - K050035
Device Classification Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K050035
Device Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant
ELEKTA NEUROMAG OY
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM SE-103 93 SE
Other 510(k) Applications for this Company
Contact
LOUISE LINDBLAD
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2005
Decision Date
01/25/2005
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
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