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510(k) Data Aggregation

    K Number
    K954772
    Device Name
    QUICKELS QS 200 SYSTEM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1996-07-11

    (272 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K864260
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl sk in surface electrode to a patient or subject being dur ing measured standard electrocardiography workups. The electrodes can be reused.

    Device Description

    The Quickels QS 200 System is a device that allows reusable AgCl electrodes be attached to the skin surface to using Suction rather than an adhesive.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, its intended use, and technological characteristics, as well as a comparison to predicate devices, but it does not include any details on acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement. This document appears to be a 510(k) summary for device clearance rather than a clinical study report.

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