Device Classification Name |
pump, infusion
|
510(k) Number |
K042609 |
Device Name |
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE |
Applicant |
HOSPIRA, INC. |
275 N. FIELD DRIVE |
LAKE FOREST,
IL
60045 -5045
|
|
Applicant Contact |
Ray Silkaitis |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/24/2004 |
Decision Date | 10/06/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|