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

    MRI ECG Patient Cable

    K Number: K192852 · Decision Mar 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    27
    Review Days
    177

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    Basic Information

    Device Name
    MRI ECG Patient Cable
    K Number
    K192852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ivy Biomedical Systems, Inc.
    Date Received
    October 3, 2019
    Decision Date
    March 28, 2020
    Product Code
    LNH
    Advisory Committee
    Radiology
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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