Device Classification Name |
Pump, Infusion
|
510(k) Number |
K000328 |
Device Name |
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP |
Applicant |
MEDEX, INC. |
6250 SHIER RINGS RD. |
DUBLIN,
OH
40316
|
|
Applicant Contact |
CATHY CHENETSKI |
Correspondent |
MEDEX, INC. |
6250 SHIER RINGS RD. |
DUBLIN,
OH
40316
|
|
Correspondent Contact |
CATHY CHENETSKI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/02/2000 |
Decision Date | 05/09/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|