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510(k) Data Aggregation

    K Number
    K192852
    Device Name
    MRI ECG Patient Cable
    Manufacturer
    Ivy Biomedical Systems, Inc.
    Date Cleared
    2020-03-28

    (177 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MRI ECG Patient Cable

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MRI ECG Patient Cable is intended to connect electrodes placed on a patient to a host device. The cable is intended for use in up to 3.0T in MRI environments. It is used in a professional healthcare facility environment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRI ECG Patient Cable). This letter does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document. The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

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