Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K090745 |
Device Name |
ARTIS ZEE / ZEEGOS WITH SW VC14 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, E-50 |
MALVERN,
PA
19355
|
|
Applicant Contact |
GARY JOHNSON |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, E-50 |
MALVERN,
PA
19355
|
|
Correspondent Contact |
GARY JOHNSON |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 03/20/2009 |
Decision Date | 06/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|