Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K961008 |
Device Name |
AUTOMIX 3+3/AS COMPOUNDER SYSTEM |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
MARCIA MARCONI |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
MARCIA MARCONI |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/12/1996 |
Decision Date | 10/10/1997 |
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
|
|
|