Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K875308 |
Device Name |
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 |
Applicant |
SELF REGULATION SYSTEMS, INC. |
14770 N.E. 95TH ST. |
REDMOND,
WA
98052
|
|
Applicant Contact |
CARL R CHRISTINE |
Correspondent |
SELF REGULATION SYSTEMS, INC. |
14770 N.E. 95TH ST. |
REDMOND,
WA
98052
|
|
Correspondent Contact |
CARL R CHRISTINE |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 12/29/1987 |
Decision Date | 02/26/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|