| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K854277 |
| Device Name |
NEUROPATH 4000 |
| Applicant |
| Therapeutic Technologies, Inc. |
| Int'L Sq. #400 |
| 1825 Eye St. NW |
|
Washington,
DC
20006
|
|
| Applicant Contact |
RICHARD T NEY |
| Correspondent |
| Therapeutic Technologies, Inc. |
| Int'L Sq. #400 |
| 1825 Eye St. NW |
|
Washington,
DC
20006
|
|
| Correspondent Contact |
RICHARD T NEY |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Date Received | 10/23/1985 |
| Decision Date | 01/21/1986 |
| 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
|
|
|