| Device Classification Name |
Nystagmograph
|
| 510(k) Number |
K863424 |
| Device Name |
COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE |
| Applicant |
| Micromedical Technologies, Inc. |
| Rr Box 176-1 |
| Rtes 4 And 104 |
|
Auburn,
IL
62615
|
|
| Applicant Contact |
RICHARD D MILES,PHD |
| Correspondent |
| Micromedical Technologies, Inc. |
| Rr Box 176-1 |
| Rtes 4 And 104 |
|
Auburn,
IL
62615
|
|
| Correspondent Contact |
RICHARD D MILES,PHD |
| Regulation Number | 882.1460 |
| Classification Product Code |
|
| Date Received | 09/04/1986 |
| Decision Date | 03/23/1987 |
| 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
|
|
|