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510(k) Data Aggregation

    K Number
    K140237
    Device Name
    DISPOSABLE NEBULIZER SET
    Date Cleared
    2015-01-08

    (343 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. The Disposable Nebulizer Set is for less than 24 hours cumulative use. The disposal nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. It is intended for adult patients consistent with the indications for the aerosol medication The Disposable Nebulizer Set is for single use for less than 24 hours cumulative use
    Device Description
    The disposal nebulizer set is designed and manufactured by SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD. The disposal nebulizer sets are made of PVC; they are supplied as sterile. It is for single use for less than 24 hours cumulative use. The nebulizer set consists of a hollow tube connected to a nebulizer jar/bottle, which holds the liquid medication; a compressed gas source respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The Weikang Disposable Nebulizer Set is a light weight portable aerosol Nebulizer which uses a compressor that causes compressed air to flow at high velocity through a liquid medicine to turn it into an aerosol which is inhaled by the patient.
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    K Number
    K140228
    Device Name
    DISPOSABLE TRACHEAL TUBE
    Date Cleared
    2014-12-18

    (322 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable tracheal tube is intended for oral or nasal intubation and for airway management.
    Device Description
    The tracheal tubes are disposable and are supplied sterile. The tracheal tubes are available in a number of sizes/variants. All variants are primarily made from polyvinyl chloride. The tracheal tube without cuff is composed of a tubular body and a standard connector, and the cuffed tube is composed of tubular body, cuff, oneway valve, pilot balloon, inflating tube and standard connector. All variants have a Murphy eye. As the device functions in airway management/gas transport for anesthesia or resuscitation, it is required to be flexible and resistant to kinking. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed.
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