K242752
- 510(k) number
- K242752
- Device name
- MRidium 3870 MRI Infusion Pump System (3870)
- Applicant
- Iradimed Corporation FL · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2025-05-28
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242752.pdf
Official FDA record: K242752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.