BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3880 MRI Patient Monitoring System

    Reg #: 3005053560 · FEI: 3005053560 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IRADIMED CORPORATION
    Registration Number
    3005053560
    FEI Number
    3005053560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1025 Willa Springs Dr
    City
    Winter Springs
    State
    FL
    ZIP
    32708
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180903

    Owner / Operator

    Firm Name
    IRADIMED CORPORATION
    Operator Number
    9070201
    Address
    1025 WILLA SPRINGS DRIVE, --
    City
    Winter Springs
    State
    FL
    Postal Code
    32708
    Country
    US
    Correspondent
    Daniel L Bennett

    Products

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

    Proprietary Names

    3880 MRI Patient Monitoring System

    Establishment Types

    Manufacture Medical Device