Device Classification Name |
reduced- montage standard electroencephalograph
|
510(k) Number |
K130013 |
Device Name |
X4 SYSTEM |
Applicant |
ADVANCED BRAIN MONITORING INC. |
W324 S3649 COUNTY ROAD E |
DOUSMAN,
WI
53118
|
|
Applicant Contact |
ADRIENNE LENZ |
Correspondent |
ADVANCED BRAIN MONITORING INC. |
W324 S3649 COUNTY ROAD E |
DOUSMAN,
WI
53118
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 01/02/2013 |
Decision Date | 01/31/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|