Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K052828 |
Device Name |
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) |
Applicant |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
THOMAS KOZMA |
Correspondent |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
THOMAS KOZMA |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 10/05/2005 |
Decision Date | 02/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|