Device Classification Name |
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
|
510(k) Number |
K050035 |
Device Name |
ELEKTA NEUROMAG WITH MAXWELL FILTER |
Applicant |
ELEKTA NEUROMAG OY |
KUNGSTENSGATAN 18 |
PO BOX 7593 |
STOCKHOLM,
SE
SE-103 93
|
|
Applicant Contact |
LOUISE LINDBLAD |
Correspondent |
ELEKTA NEUROMAG OY |
KUNGSTENSGATAN 18 |
PO BOX 7593 |
STOCKHOLM,
SE
SE-103 93
|
|
Correspondent Contact |
LOUISE LINDBLAD |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/07/2005 |
Decision Date | 01/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|