| Device Classification Name |
Screen, Tangent, Projection, Ac-Powered
|
| 510(k) Number |
K914896 |
| Device Name |
FRIEDMANN ANALYSER 3 |
| Applicant |
| Clement Clarke, Inc. |
| Airmed House, Edinburgh Way |
| Harlow, Essex Cm20 2ed |
|
England,
GB
|
|
| Applicant Contact |
MICHAEL J WILKINSON |
| Correspondent |
| Clement Clarke, Inc. |
| Airmed House, Edinburgh Way |
| Harlow, Essex Cm20 2ed |
|
England,
GB
|
|
| Correspondent Contact |
MICHAEL J WILKINSON |
| Regulation Number | 886.1810 |
| Classification Product Code |
|
| Date Received | 10/31/1991 |
| Decision Date | 01/23/1992 |
| 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
|
|
|