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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion
510(k) Number K143369
Device Name MRidium 3860+ MRI infusion Pump/ Monitoring System
Applicant
IRADIMED CORPORATION
1025 WILLA SPRINGS DRIVE
WINTER SPRINGS,  FL  32708
Applicant Contact FRANCIS X CASEY
Correspondent
IRADIMED CORPORATION
1025 WILLA SPRINGS DRIVE
WINTER SPRINGS,  FL  32708
Correspondent Contact FRANCIS X CASEY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/25/2014
Decision Date 12/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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