Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K141316 |
Device Name |
COGNISION EEG/EP SYSTEM |
Applicant |
NEURONETRIX SOLUTIONS |
816 CONGRESS AVENUE, SUITE 1400 |
AUSTIN,
TX
78701
|
|
Applicant Contact |
CHERYL FISHER |
Correspondent |
NEURONETRIX SOLUTIONS |
816 CONGRESS AVENUE, SUITE 1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
CHERYL FISHER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/20/2014 |
Decision Date | 02/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|