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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name source localization software for electroencephalograph or magnetoencephalograph
510(k) Number K050035
Device Name ELEKTA NEUROMAG WITH MAXWELL FILTER
Applicant
ELEKTA NEUROMAG OY
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM,  SE SE-103 93
Applicant Contact LOUISE LINDBLAD
Correspondent
ELEKTA NEUROMAG OY
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM,  SE SE-103 93
Correspondent Contact LOUISE LINDBLAD
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received01/07/2005
Decision Date 01/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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