Device Classification Name |
Programmer, Changer, Film/Cassette, Radiographic
|
510(k) Number |
K874451 |
Device Name |
OMNIPLANE 200 FILM CHANGER SYSTEM |
Applicant |
MEDRAD, INC. |
271 KAPPA DR. |
PITTSBURGH,
PA
15238 -2870
|
|
Applicant Contact |
RUEY C DEMPSEY |
Correspondent |
MEDRAD, INC. |
271 KAPPA DR. |
PITTSBURGH,
PA
15238 -2870
|
|
Correspondent Contact |
RUEY C DEMPSEY |
Regulation Number | 892.1870
|
Classification Product Code |
|
Date Received | 10/28/1987 |
Decision Date | 02/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|