Device Classification Name |
system, x-ray, angiographic
|
510(k) Number |
K052076 |
Device Name |
DAR-8000I |
Applicant |
SHIMADZU MEDICAL SYSTEMS |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Applicant Contact |
RANDAL WALKER |
Correspondent |
SHIMADZU MEDICAL SYSTEMS |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Correspondent Contact |
RANDAL WALKER |
Regulation Number | 892.1600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2005 |
Decision Date | 09/02/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|