| Device Classification Name |
device, biofeedback
|
|---|
| 510(k) Number |
K914920 |
|---|
| Device Name |
BIOFEEDBACK SYSTEM/3 |
|---|
| Applicant |
| DAVICON, INC. |
| C/O MEDICAL DEVICE CONSULTANTS |
| 45 WEST STREET, SUITE 2 |
|
ATTLEBORO,
MA
02703
|
|
| Applicant Contact |
LYNNE ARONSON |
| Correspondent |
| DAVICON, INC. |
| C/O MEDICAL DEVICE CONSULTANTS |
| 45 WEST STREET, SUITE 2 |
|
ATTLEBORO,
MA
02703
|
|
| Correspondent Contact |
LYNNE ARONSON |
| Regulation Number | 882.5050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/04/1991 |
|---|
| Decision Date | 11/16/1992 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|