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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 K081430
Device Name ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
Applicant
Elekta Neuromag OY
P.O. Box 68
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Elekta Neuromag OY
P.O. Box 68
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received05/21/2008
Decision Date 07/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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