Device Classification Name |
Pump, Infusion
|
510(k) Number |
K141789 |
Device Name |
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE |
Applicant |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
Yuliya Matlin |
Correspondent |
ICU Medical Inc |
600 N. Field Drive |
Lake Forest,
IL
60045
|
|
Correspondent Contact |
Jeannette Marinoni |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/02/2014 |
Decision Date | 01/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|