| Device Classification Name |
Camera, Multi Format, Radiological
|
| 510(k) Number |
K840385 |
| Device Name |
VIDEO PRINT |
| Applicant |
| Advanced Instruments, Inc. |
| Shorashim |
|
|
|
| Correspondent |
| Advanced Instruments, Inc. |
| Shorashim |
|
|
|
| Regulation Number | 892.2040 |
| Classification Product Code |
|
| Date Received | 01/30/1984 |
| Decision Date | 02/27/1984 |
| 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
|
|
|