| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K141102 |
| Device Name |
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE |
| Applicant |
| HOSPIRA, INC. |
| 275 NORTH FIELD DR. |
|
LAKE FOREST,
IL
60045
|
|
| Applicant Contact |
TOM GUTIERREZ |
| Correspondent |
| HOSPIRA, INC. |
| 275 NORTH FIELD DR. |
|
LAKE FOREST,
IL
60045
|
|
| Correspondent Contact |
TOM GUTIERREZ |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 04/29/2014 |
| Decision Date | 07/08/2014 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|