Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K970627 |
Device Name |
E. CAM COINCIDENCE MODE (CM) |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
2501 NORTH BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Applicant Contact |
PAUL G ORIS |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
2501 NORTH BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Correspondent Contact |
PAUL G ORIS |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 02/19/1997 |
Decision Date | 09/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|