Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K972723 |
Device Name |
BIO TROL |
Applicant |
MINDMEDIA LABS, INC. |
1036 WILLA LAKE CIRCLE |
OVEIDA,
FL
32765
|
|
Applicant Contact |
TOM ALLEN |
Correspondent |
MINDMEDIA LABS, INC. |
1036 WILLA LAKE CIRCLE |
OVEIDA,
FL
32765
|
|
Correspondent Contact |
TOM ALLEN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 07/21/1997 |
Decision Date | 10/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|