| Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
| 510(k) Number |
K842191 |
| Device Name |
DIGISTORE 50 |
| Applicant |
| Vas Corp. |
| 2525 Maricopa St. |
|
Torrance ,
CA
90503
|
|
| Applicant Contact |
KAREN A BARON |
| Correspondent |
| Vas Corp. |
| 2525 Maricopa St. |
|
Torrance ,
CA
90503
|
|
| Correspondent Contact |
KAREN A BARON |
| Regulation Number | 892.1650 |
| Classification Product Code |
|
| Date Received | 06/04/1984 |
| Decision Date | 10/25/1984 |
| 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
|
|
|