| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K942861 |
| Device Name |
MEDVISION ENVIROMENT/MEDVISION 2.0 |
| Applicant |
| Evergreen Technologies, Inc. |
| Main St. |
| P.O. Box 795 |
|
Castine,
ME
04421
|
|
| Applicant Contact |
KAREN SIEGEL |
| Correspondent |
| Evergreen Technologies, Inc. |
| Main St. |
| P.O. Box 795 |
|
Castine,
ME
04421
|
|
| Correspondent Contact |
KAREN SIEGEL |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 06/17/1994 |
| Decision Date | 12/07/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|