Device Classification Name |
pump, infusion
|
510(k) Number |
K041191 |
Device Name |
COLLEAGUE VOLUMETRIC INFUSION PUMPS |
Applicant |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
JENNIFER M PAINE |
Correspondent |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
JENNIFER M PAINE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/06/2004 |
Decision Date | 06/25/2004 |
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
|
|
|