Device Classification Name |
Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K212684 |
Device Name |
BrainView QEEG Software |
Applicant |
Medeia, Inc. |
7 W Figueroa St, Suite 300 |
Santa Barbara,
CA
93101
|
|
Applicant Contact |
Slav Danev |
Correspondent |
Compliance and Regulatory Services LLC |
3771 Southbrook Dr |
Dayton,
OH
45430
|
|
Correspondent Contact |
Daniel Lehtonen |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/24/2021 |
Decision Date | 01/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|