| Device Classification Name |
System, X-Ray, Film Marking, Radiographic
|
| 510(k) Number |
K915088 |
| Device Name |
KODAK MIN-R IDENTIFICATION CAMERA |
| Applicant |
| Eastman Kodak Company |
| 343 State St. |
|
Rochester,
NY
14650
|
|
| Applicant Contact |
NORMAN H GEIL |
| Correspondent |
| Eastman Kodak Company |
| 343 State St. |
|
Rochester,
NY
14650
|
|
| Correspondent Contact |
NORMAN H GEIL |
| Regulation Number | 892.1640 |
| Classification Product Code |
|
| Date Received | 11/12/1991 |
| Decision Date | 12/02/1991 |
| 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
|
|
|