Device Classification Name |
pump, infusion
|
510(k) Number |
K983975 |
Device Name |
BELMONT FLUID MANAGEMENT SYSTEM (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 | 11/09/1998 |
Decision Date | 11/30/1998 |
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
|
|
|