Device Classification Name |
physiological signal based seizure monitoring system
|
510(k) Number |
K200276 |
Device Name |
SPEAC System |
Applicant |
Brain Sentinel, Inc. |
8023 Vantage Drive Suite 216 |
San Antonio,
TX
78230
|
|
Applicant Contact |
Richard Waite |
Correspondent |
Brain Sentinel, Inc. |
8023 Vantage Drive Suite 216 |
San Antonio,
TX
78230
|
|
Correspondent Contact |
Richard Waite |
Regulation Number | 882.1580
|
Classification Product Code |
|
Date Received | 02/04/2020 |
Decision Date | 02/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01874600
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|