FDA.report

510(k) K242752

Device
MRidium 3870 MRI Infusion Pump System (3870)
Applicant
Iradimed Corporation
510(k) number
K242752
Product code
FRN
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-28
Date received
2024-09-12
Regulation
880.5725
Classification name
Pump, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Steven Kachelmeyer
Address
1025 Willa Springs Dr. Winter Springs FL US 32708 32708

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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