| Device Classification Name |
Recorder, Attention Task Performance
|
| 510(k) Number |
K854903 |
| FOIA Releasable 510(k) |
K854903
|
| Device Name |
GORDON DIAGNOSTIC SYSTEM MODEL I |
| Applicant |
| Clinical Diagnostics, Inc. |
| 300 E. Mineral Ave., #6 |
|
Littleton,
CO
80122
|
|
| Applicant Contact |
BRUCE MEYER |
| Correspondent |
| Clinical Diagnostics, Inc. |
| 300 E. Mineral Ave., #6 |
|
Littleton,
CO
80122
|
|
| Correspondent Contact |
BRUCE MEYER |
| Classification Product Code |
|
| Date Received | 12/09/1985 |
| Decision Date | 06/02/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|