| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K873418 |
| Device Name |
BODYLOG STRESS REDUCTION PACKAGE |
| Applicant |
| Bodylog, Inc. |
| 34 Maple Ave. |
|
Armonk,
NY
10504
|
|
| Applicant Contact |
BENJAMIN GEIZHALS |
| Correspondent |
| Bodylog, Inc. |
| 34 Maple Ave. |
|
Armonk,
NY
10504
|
|
| Correspondent Contact |
BENJAMIN GEIZHALS |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Date Received | 08/26/1987 |
| Decision Date | 12/17/1987 |
| 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
|
|
|