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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 K091393
Device Name ELEKTA NEUROMAG WITH MAXFILTER
Applicant
ELEKTA NEUROMAG OY
8726 FERRARA CT.
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
ELEKTA NEUROMAG OY
8726 FERRARA CT.
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
OLY  
Date Received05/11/2009
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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