Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K003014 |
Device Name |
SOMATOM EMOTION MS |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
KATHLEEN RUTHERFORD |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
REINER KRUMME |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 09/27/2000 |
Decision Date | 10/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|