Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K150493 |
Device Name |
Sensis |
Applicant |
Siemens Medical Solutions, Inc. |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Patricia D Jones |
Correspondent |
Siemens Medical Solutions, Inc. |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Patricia D Jones |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 02/25/2015 |
Decision Date | 06/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|