| Device Classification Name |
Perimeter, Automatic, Ac-Powered
|
| 510(k) Number |
K853290 |
| Device Name |
TECHNA VISION AUTO-PERIMETER |
| Applicant |
| Techna Vision |
| 11489 Woodside Ave. |
|
Santee,
CA
92071
|
|
| Applicant Contact |
JAMES TERRY |
| Correspondent |
| Techna Vision |
| 11489 Woodside Ave. |
|
Santee,
CA
92071
|
|
| Correspondent Contact |
JAMES TERRY |
| Regulation Number | 886.1605 |
| Classification Product Code |
|
| Date Received | 08/05/1985 |
| Decision Date | 11/12/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|