Device Classification Name |
pump, infusion
|
510(k) Number |
K050301 |
Device Name |
MRIDIUM 3850 MRI PUMP SYSTEM |
Applicant |
IRADIMED CORPORATION |
7457 ALOMA AVENUE |
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 | 02/08/2005 |
Decision Date | 03/24/2005 |
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
|
|
|