Device Classification Name |
computer, diagnostic, pre-programmed, single-function
|
510(k) Number |
K113821 |
Device Name |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
Applicant |
TRANSONIC SYSTEMS, INC. |
34 Dutch Mill Rd |
ITHACA,
NY
14850
|
|
Applicant Contact |
NAVEEN THURAMALLA |
Correspondent |
TRANSONIC SYSTEMS, INC. |
34 Dutch Mill Rd |
ITHACA,
NY
14850
|
|
Correspondent Contact |
NAVEEN THURAMALLA |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 12/27/2011 |
Decision Date | 09/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00851422 NCT00852254 NCT01662141
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|