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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 K242752
Device Name MRidium 3870 MRI Infusion Pump System (3870)
Applicant
Iradimed Corporation
1025 Willa Springs Dr.
Winter Springs,  FL  32708
Applicant Contact Steven Kachelmeyer
Correspondent
Iradimed Corporation
1025 Willa Springs Dr.
Winter Springs,  FL  32708
Correspondent Contact Daniel Bennett
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FOX   LHI  
Date Received09/12/2024
Decision Date 05/28/2025
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
Predetermined Change
Control Plan Authorized		 No
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