| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K843311 |
| Device Name |
IV ADMIN. SET FOR MVP 1 INFUSION PUMP |
| Applicant |
| Ziehm International, Inc. |
|
7600 Ridge Blvd Brooklun,
NY
|
|
| Correspondent |
| Ziehm International, Inc. |
|
7600 Ridge Blvd Brooklun,
NY
|
|
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 08/23/1984 |
| Decision Date | 03/13/1985 |
| 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
|
|
|