Device Classification Name |
Pump, Infusion
|
510(k) Number |
K002380 |
Device Name |
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM |
Applicant |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
VICKI L DREWS |
Correspondent |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
VICKI L DREWS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2000 |
Decision Date | 09/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|