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510(k) Data Aggregation

    K Number
    K991105
    Device Name
    ECG ELECTRODE (VARIOUS)
    Manufacturer
    CONMED CORP.
    Date Cleared
    1999-11-26

    (239 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECG ELECTRODE (VARIOUS)

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

    An electrical conductor applied to a patient's skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for an ECG electrode (various) and the associated "Indications for Use" statement. It does not contain information on acceptance criteria, device performance, or details of a study to prove the device meets these criteria. This type of document is a regulatory approval, confirming substantial equivalence to a predicate device, rather than a scientific study report.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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