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FDA 510(k) Application Details - K092844
Device Classification Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K092844
Device Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant
ELECTRICAL GEODESICS, INC.
1600 MILLRACE DR.
SUITE 307
EUGENE, OR 97403-1995 US
Other 510(k) Applications for this Company
Contact
PAUL HOLMAN
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
09/15/2009
Decision Date
12/21/2010
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
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