BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MRidium 3860+ MRI infusion Pump/ Monitoring System

    K Number: K143369 · Decision Dec 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    751

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MRidium 3860+ MRI infusion Pump/ Monitoring System
    K Number
    K143369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iradimed Corporation
    Date Received
    November 25, 2014
    Decision Date
    December 15, 2016
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.

    FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA Spectrum Infusion Pump with Master Drug Library

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MRidium 3870 MRI Infusion Pump System (3870)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Infusion System with Guardrails Suite MX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Plum Solo™ Precision IV Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Iradimed Corporation

    K Number Device Name
    K242752 MRidium 3870 MRI Infusion Pump System (3870)
    K180903 3880 MRI Patient Monitoring System
    K182900 3880 MRI Patient Monitoring System
    K172200 3880 MRI Patient Monitoring System
    K090087 MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
    K050301 MRIDIUM 3850 MRI PUMP SYSTEM