| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K871881 |
| Device Name |
MODEL 3000 INFUSION PUMP |
| Applicant |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1 Becton Dr. |
|
Franklin Lakes,
NJ
07417
|
|
| Applicant Contact |
J ARNSBERGER |
| Correspondent |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1 Becton Dr. |
|
Franklin Lakes,
NJ
07417
|
|
| Correspondent Contact |
J ARNSBERGER |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 05/14/1987 |
| Decision Date | 01/06/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|