Device Classification Name |
image-intensified fluoroscopic x-ray system, mobile
|
510(k) Number |
K973598 |
Device Name |
SIREMOBIL CO2 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
KATHLEEN RUTHERFORD |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
KATHLEEN RUTHERFORD |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 09/22/1997 |
Decision Date | 11/10/1997 |
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
|
|
|