Device Classification Name |
pump, infusion
|
510(k) Number |
K121613 |
Device Name |
AGILIA INFUSION SYSTEM |
Applicant |
FRESENIUS KABI AG |
THREE CORPORATE DRIVE |
LAKE ZURICH,
IL
60047
|
|
Applicant Contact |
CHERYL ROSCHER |
Correspondent |
FRESENIUS KABI AG |
THREE CORPORATE DRIVE |
LAKE ZURICH,
IL
60047
|
|
Correspondent Contact |
CHERYL ROSCHER |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 05/01/2013 |
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
|
|
|