Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K933473 |
Device Name |
CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM |
Applicant |
SHIMADZU CORP. |
1 NISHINOKYO-KUWABARACHO |
NAKAYGO-KU |
KYOTO CITY 604 JAPAN,
JP
|
|
Applicant Contact |
HIROSLHI ISKHIHARA |
Correspondent |
SHIMADZU CORP. |
1 NISHINOKYO-KUWABARACHO |
NAKAYGO-KU |
KYOTO CITY 604 JAPAN,
JP
|
|
Correspondent Contact |
HIROSLHI ISKHIHARA |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 07/15/1993 |
Decision Date | 11/24/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|