Device Classification Name |
catheter, oximeter, fiber-optic
|
510(k) Number |
K061450 |
Device Name |
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS |
Applicant |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
THOMAS SAMPOGNA |
Correspondent |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
THOMAS SAMPOGNA |
Regulation Number | 870.1230
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/25/2006 |
Decision Date | 08/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|