Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K962896 |
Device Name |
KODAK DIGITAL SCIENCE REMOTE CASSETTE |
Applicant |
EASTMAN KODAK COMPANY |
901 ELMGROVE RD. |
ROCHESTER,
NY
14653 -0002
|
|
Applicant Contact |
JOHN LE CLAIR |
Correspondent |
EASTMAN KODAK COMPANY |
901 ELMGROVE RD. |
ROCHESTER,
NY
14653 -0002
|
|
Correspondent Contact |
JOHN LE CLAIR |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 07/25/1996 |
Decision Date | 09/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|