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510(k) Data Aggregation
K Number
K212395Device Name
Nebulizer
Manufacturer
Date Cleared
2022-03-25
(235 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Homed Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.
Device Description
The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The JLI nebulizer is disposable, single-patient-use.
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