ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING


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

Correspodent Contact daniel kamm
Regulation Number 882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received 05/21/2008
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