Device Classification Name |
Computer, Diagnostic, Pre-Programmed, Single-Function
|
510(k) Number |
K080116 |
Device Name |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
Applicant |
TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. |
ITHACA,
NY
14850
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. |
ITHACA,
NY
14850
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 01/16/2008 |
Decision Date | 09/08/2008 |
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
|
|
|