| 510(k) Number |
K837213 |
| Device Name |
MULTI-USER IMAGING AND ACQUISITION TERMINALS |
| Applicant |
| Computer Design & Applications, Inc. |
| 8 Centennial Dr. |
|
Peabody,
MA
01961
|
|
| Correspondent |
| Computer Design & Applications, Inc. |
| 8 Centennial Dr. |
|
Peabody,
MA
01961
|
|
| Date Received | 02/02/1983 |
| Decision Date | 04/04/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|