Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K932445 |
Device Name |
SIRESKOP CX |
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 | 05/20/1993 |
Decision Date | 09/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|