| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K872495 |
| Device Name |
BIOCOMP 2001 BIOFEEDBACK DEVICE |
| Applicant |
| Biofeedback Research Institute, Inc. |
| 6399 Wilshire Blvd., Suite 1010 |
|
Los Angeles,
CA
90048
|
|
| Applicant Contact |
HERSHEL TOOMIM |
| Correspondent |
| Biofeedback Research Institute, Inc. |
| 6399 Wilshire Blvd., Suite 1010 |
|
Los Angeles,
CA
90048
|
|
| Correspondent Contact |
HERSHEL TOOMIM |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Date Received | 06/24/1987 |
| Decision Date | 08/04/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|