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 Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/12/2004 |
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
|
|
|