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

    3880 MRI Patient Monitoring System

    K Number: K182900 · Decision Dec 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    3880 MRI Patient Monitoring System
    K Number
    K182900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iradimed Corporation
    Date Received
    October 16, 2018
    Decision Date
    December 14, 2018
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Iradimed Corporation

    K Number Device Name
    K242752 MRidium 3870 MRI Infusion Pump System (3870)
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    K172200 3880 MRI Patient Monitoring System
    K143369 MRidium 3860+ MRI infusion Pump/ Monitoring System
    K090087 MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
    K050301 MRIDIUM 3850 MRI PUMP SYSTEM