LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990115
    Device Name
    DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
    Manufacturer
    MAERSK MEDICAL A/S
    Date Cleared
    1999-12-06

    (327 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K950476
    Why did this record match?
    Device Name :

    DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440

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

    ECG monitoring electrodes for short term use (

    Device Description

    Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

    AI/ML Overview

    The provided document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for ECG monitoring electrodes, detailing administrative information, device names, predicate devices, device description, and intended use, along with the FDA's letter of substantial equivalence. It does not provide performance data, study design, or methodology for assessing the device's performance against specific criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1