| Device Classification Name |
Illuminator, Radiographic-Film
|
| 510(k) Number |
K872245 |
| Device Name |
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM |
| Applicant |
| General Electric Co. |
| P.O. Box 414 |
|
Milwaukee,
WI
53201
|
|
| Applicant Contact |
LARRY KROGER |
| Correspondent |
| General Electric Co. |
| P.O. Box 414 |
|
Milwaukee,
WI
53201
|
|
| Correspondent Contact |
LARRY KROGER |
| Regulation Number | 892.1890 |
| Classification Product Code |
|
| Date Received | 06/11/1987 |
| Decision Date | 06/19/1987 |
| 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
|
|
|