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
|
|
|