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510(k) Data Aggregation
K Number
K242931Device Name
HFT750U
Manufacturer
MEKICS Co., Ltd.
Date Cleared
2025-05-15
(232 days)
Product Code
MNT
Regulation Number
868.5895Why 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.
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