Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K042158 |
Device Name |
KODAK MEDICAL IMAGER 300 |
Applicant |
EASTMAN KODAK COMPANY |
1 IMATION WAY |
304-3B-61 |
OAKDALE,
MN
55128 -3414
|
|
Applicant Contact |
STEPHEN SLAVENS |
Correspondent |
EASTMAN KODAK COMPANY |
1 IMATION WAY |
304-3B-61 |
OAKDALE,
MN
55128 -3414
|
|
Correspondent Contact |
STEPHEN SLAVENS |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 08/10/2004 |
Decision Date | 09/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|