Device Classification Name |
Pump, Infusion
|
510(k) Number |
K083689 |
Device Name |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
Applicant |
B. BRAUN MEDICAL, INC. |
1601 WALLACE DR., SUITE 150 |
CARROLLTON,
TX
75006
|
|
Applicant Contact |
LINDA MORGAN |
Correspondent |
B. BRAUN MEDICAL, INC. |
1601 WALLACE DR., SUITE 150 |
CARROLLTON,
TX
75006
|
|
Correspondent Contact |
LINDA MORGAN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 12/12/2008 |
Decision Date | 07/01/2009 |
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
|
|
|