Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K142036 |
Device Name |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Applicant Contact |
TRACY MADDOCK |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Correspondent Contact |
TRACY MADDOCK |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/28/2014 |
Decision Date | 08/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|