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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 K041264
Device Name ELEKTA OY
Applicant
Elekta Neuromag OY
Elimaenkatu 22 B, Po Bx 68
Helsinki,  FI FIN-00511
Applicant Contact BIRGITTA FAGERSTROM
Correspondent
Elekta Neuromag OY
Elimaenkatu 22 B, Po Bx 68
Helsinki,  FI FIN-00511
Correspondent Contact BIRGITTA FAGERSTROM
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received05/12/2004
Decision Date 08/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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