Device Classification Name |
Pump, Infusion
|
510(k) Number |
K090087 |
Device Name |
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM |
Applicant |
IRADIMED CORPORATION |
7457 ALOMA AVE., SUITE 201 |
WINTER PARK,
FL
32792
|
|
Applicant Contact |
FRANCIS X CASEY |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 01/13/2009 |
Decision Date | 04/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|