Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K980373 |
Device Name |
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE |
Applicant |
ULTRAMIND INTERNATIONAL LTD. |
117 AHUZAH ST. |
RA'ANANNA,
IL
43373
|
|
Applicant Contact |
SHOSHANA FRIEDMAN |
Correspondent |
ULTRAMIND INTERNATIONAL LTD. |
117 AHUZAH ST. |
RA'ANANNA,
IL
43373
|
|
Correspondent Contact |
SHOSHANA FRIEDMAN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 01/30/1998 |
Decision Date | 04/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|