Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242931
    Device Name
    HFT750U
    Manufacturer
    MEKICS Co., Ltd.
    Date Cleared
    2025-05-15

    (232 days)

    Product Code
    MNT
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEKICS Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. The device provides heated and humidified gas to the patient. The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included. The High Flow mode has a flow range from 1 to 60 lpm. The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician. It is not intended for life support.
    Device Description
    This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions. It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.
    Ask a Question

    Page 1 of 1