| Device Classification Name |
Electromyograph, Diagnostic
|
| 510(k) Number |
K880976 |
| Device Name |
AL-200B MUSCLE ACTIVITY INTEGRATOR |
| Applicant |
| Aaron Laboratories, Inc. |
| P.O. Box 29264 |
|
San Antonio,
TX
78229
|
|
| Applicant Contact |
CHARLES G BURGAR |
| Correspondent |
| Aaron Laboratories, Inc. |
| P.O. Box 29264 |
|
San Antonio,
TX
78229
|
|
| Correspondent Contact |
CHARLES G BURGAR |
| Regulation Number | 890.1375 |
| Classification Product Code |
|
| Date Received | 03/08/1988 |
| Decision Date | 04/13/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|