Device Classification Name |
Pump, Infusion
|
510(k) Number |
K981816 |
Device Name |
CUE AMBULATORY VOLUMETRIC INFUSION PUMP |
Applicant |
BECTON DICKINSON CURLIN, LLC. |
15751 GRAHAM ST. |
HUNTINGTON BEACH,
CA
92649
|
|
Applicant Contact |
CHARLES J WELLE |
Correspondent |
BECTON DICKINSON CURLIN, LLC. |
15751 GRAHAM ST. |
HUNTINGTON BEACH,
CA
92649
|
|
Correspondent Contact |
CHARLES J WELLE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/22/1998 |
Decision Date | 12/04/1998 |
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
|
|
|