| Device Classification Name |
Light, Microscope
|
| 510(k) Number |
K874750 |
| Device Name |
VIDEO ANALYZER 4000 |
| Applicant |
| SCIENTIFIC IMAGING, INC. |
| 21 CASTLE AVE. |
|
FAIRFIELD,
CT
06830
|
|
| Applicant Contact |
STEVEN R GRIFFIN |
| Correspondent |
| SCIENTIFIC IMAGING, INC. |
| 21 CASTLE AVE. |
|
FAIRFIELD,
CT
06830
|
|
| Correspondent Contact |
STEVEN R GRIFFIN |
| Regulation Number | 864.3600 |
| Classification Product Code |
|
| Date Received | 11/18/1987 |
| Decision Date | 04/25/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Pathology
|
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|