Device Classification Name |
pump, infusion
|
510(k) Number |
K091855 |
Device Name |
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 |
Applicant |
BELMONT INSTRUMENT CORP. |
780 BOSTON RD. |
BILLERICA,
MA
01821
|
|
Applicant Contact |
URAIWAN LABADINI |
Correspondent |
BELMONT INSTRUMENT CORP. |
780 BOSTON RD. |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
URAIWAN LABADINI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/23/2009 |
Decision Date | 07/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|