| Device Classification Name |
Camera, Multi Format, Radiological
|
| 510(k) Number |
K850184 |
| Device Name |
MEDICAL MULTI-IMAGE CAMERA-676 |
| Applicant |
| Dunn Instruments, Inc. |
| 544 Second St. |
|
San Francisco,
CA
94107
|
|
| Applicant Contact |
JOHN LEITE |
| Correspondent |
| Dunn Instruments, Inc. |
| 544 Second St. |
|
San Francisco,
CA
94107
|
|
| Correspondent Contact |
JOHN LEITE |
| Regulation Number | 892.2040 |
| Classification Product Code |
|
| Date Received | 01/18/1985 |
| Decision Date | 02/21/1985 |
| 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
|
|
|