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510(k) Data Aggregation

    K Number
    K972603
    Device Name
    ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
    Manufacturer
    DR. LEE CO., LTD.
    Date Cleared
    1998-03-11

    (243 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.

    The patient population is any patient requiring an electrocardiograph at the direction of a physician.

    The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.

    Device Description

    non-interpretive electrocardiographs

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Dr. Lee Co., Ltd. for Electrocardiographs Models 110B, 120B, and 310B. It states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It focuses on the regulatory approval process and indications for use.

    Therefore, I cannot provide the requested information based on the provided text.

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